Updated on 2024/03/22

写真a

 
SAKURAI Jun
 
Organization
Okayama University Hospital Professor
Position
Professor
External link

Degree

  • 医学博士 ( 2010.3   岡山大学 )

  • 医学博士 ( 2010.3   岡山大学大学院医歯薬学総合研究科 )

Research Interests

  • Clinical trial

  • Medical device development

  • Regulatory Science

Research Areas

  • Life Science / Medical technology assessment

Committee Memberships

  • 厚生労働省   産官学意見交換にかかる検討会  

    2023.1   

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  • 日本医療研究開発機構   新たな医療機器研究開発支援のあり方の検討に関する調査検討会  

    2023.1 - 2023.3   

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    Committee type:Government

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  • 日本医療研究開発機構   医療機器等における先進的研究開発・開発体制強靭化事業の今後のあり方に関する調査検討会委員  

    2021.11 - 2022.3   

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  • 日本IVR学会   薬事委員会  

    2020.6   

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    Committee type:Academic society

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  • 独立行政法人医薬品医療機器総合機構   専門委員  

    2015.4   

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    Committee type:Government

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  • 日本医学放射線学会   将来計画委員会  

    2014.7 - 2016.3   

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    Committee type:Academic society

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Papers

  • Prospective evaluation of core number of biopsy for renal tumor: are multiple cores preferable? Reviewed

    Toshihiro Iguchi, Yusuke Matsui, Tomohiro Toji, Jun Sakurai, Koji Tomita, Mayu Uka, Noriyuki Umakoshi, Takahiro Kawabata, Kazuaki Munetomo, Toshiharu Mitsuhashi, Takao Hiraki

    Japanese journal of radiology   2023.10

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    PURPOSE: This single-center, single-arm, prospective, open-label study was conducted to evaluate the optimal number of cores (single or multiple) in renal tumor biopsy. MATERIALS AND METHODS: Forty-four biopsies of 44 tumors (mean diameter, 2.7 ± 1.0 cm; range, 1.6-5.0 cm) were included. Biopsy was performed under ultrasound or computed tomography fluoroscopy guidance using an 18-gauge cutting needle and the co-axial method. Two or more specimens were obtained, which were divided into first and subsequent specimens. "First specimen" and "all specimens" were histologically evaluated (i.e., appropriateness of specimen, histological diagnosis, subtype, and Fuhrman grade of renal cell carcinoma [RCC]) blindly and independently by two board-certified pathologists. RESULTS: Multiple specimens were successfully and safely obtained in all the biopsies. All tumors were histologically diagnosed; 40 malignancies included 39 RCCs and 1 solitary fibrous tumor, and 4 benign lesions included 2 angiomyolipomas, 1 oncocytoma, and 1 capillary hemangioma. In all RCCs, the subtype could be determined (32 clear cell RCCs, 4 chromophobe RCCs, and 3 papillary RCCs), and the Furman grade was determined in 38 RCCs. When only the first specimen was evaluated, 22.7% of the specimens were inappropriate for diagnosis, and 34 (77.3%) were histologically diagnosed. The diagnostic yield was significantly lower than that of all specimens (P = 0.0044). Univariate analysis revealed that smaller lesions were a significant predictor of diagnostic failure (P = 0.020). CONCLUSION: Biopsy with multiple cores significantly improved diagnostic yield. Thus, operators should obtain multiple cores during renal tumor biopsy.

    DOI: 10.1007/s11604-023-01496-x

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  • A single-center, single-arm, prospective, open-label trial to evaluate the efficacy and safety of percutaneous sclerotherapy with polidocanol for painful venous malformations (SCIRO-2001): study protocol Reviewed

    Mayu Uka, Jun Sakurai, Yusuke Matsui, Toshihiro Iguchi, Koji Tomita, Noriyuki Umakoshi, Kazuaki Munetomo, Toshiharu Mitsuhashi, Hideo Gobara, Takao Hiraki

    Nagoya J. Med. Sci. 84. 746–751, 2022   2022.11

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    Authorship:Corresponding author  

    DOI: 10.18999/nagjms.84.4.746

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  • Rituximab therapy for intractable pemphigus: A multicenter, open-label, single-arm, prospective study of 20 Japanese patients. Reviewed International journal

    Jun Yamagami, Yuichi Kurihara, Takeru Funakoshi, Yasuko Saito, Ryo Tanaka, Hayato Takahashi, Hideyuki Ujiie, Hiroaki Iwata, Yoji Hirai, Keiji Iwatsuki, Norito Ishii, Jun Sakurai, Takayuki Abe, Ryo Takemura, Naomi Mashino, Masahiro Abe, Masayuki Amagai

    The Journal of dermatology   50 ( 2 )   175 - 182   2022.10

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    This was a multicenter clinical trial of rituximab, a chimeric monoclonal IgG antibody directed against CD20, for the treatment of refractory pemphigus vulgaris and pemphigus foliaceus. In total, 20 patients were treated with two doses of rituximab (1000 mg; 2 weeks apart) on days 0 and 14. The primary end point was the proportion of patients who achieved complete or partial remission on day 168 following the first rituximab dose. Of the 20 enrolled patients, 11 (55%) and four (20%) achieved complete and partial remission, respectively; therefore, remission was achieved in a total of 15 patients (75.0% [95% confidence interval, 50.9%-91.3%]). It was demonstrated that the remission rate was greater than the prespecified threshold (5%). In addition, a significant improvement in clinical score (Pemphigus Disease Area Index) and decrease in serum anti-desmoglein antibody level were observed over time. Four serious adverse events (heart failure, pneumonia, radial fracture, and osteonecrosis) were recorded in two patients, of which only pneumonia was considered causally related with rituximab. The level of peripheral blood CD19-positive B lymphocytes was decreased on day 28 after rituximab treatment and remained low throughout the study period until day 168. Our results confirm the efficacy and safety of rituximab therapy for refractory pemphigus in Japanese patients.

    DOI: 10.1111/1346-8138.16597

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  • Percutaneous cryoablation combined with prior transcatheter arterial embolization for renal cell carcinomas of 3 cm or larger: a prospective study Reviewed

    Hideo Gobara, Yusuke Matsui, Mayu Uka, Koji Tomita, Noriyuki Umakoshi, Motoo Araki, Jun Sakurai, Toshihiro Iguchi, Takao Hiraki

    International Journal of Clinical Oncology   27 ( 10 )   1589 - 1595   2022.8

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    Publishing type:Research paper (scientific journal)   Publisher:Springer Science and Business Media LLC  

    DOI: 10.1007/s10147-022-02224-7

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    Other Link: https://link.springer.com/article/10.1007/s10147-022-02224-7/fulltext.html

  • Early enlarging cavitation after percutaneous radiofrequency ablation of lung tumors: Incidence, risk factors and outcome. Reviewed International journal

    Koji Tomita, Toshihiro Iguchi, Yusuke Matsui, Mayu Uka, Noriyuki Umakoshi, Toshiharu Mitsuhashi, Jun Sakurai, Hideo Gobara, Susumu Kanazawa, Takao Hiraki

    Diagnostic and interventional imaging   103 ( 10 )   464 - 471   2022.5

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    PURPOSE: The purpose of this study was to retrospectively determine the incidence of early enlarging cavitation after percutaneous radiofrequency ablation (RFA) of lung tumor and identify risk factors associated with their occurrence. PATIENTS AND METHODS: A total of 245 patients (140 men, 105 women; mean age, 62.7 ± 11.8 [SD] years; age range: 31-87 years) with 605 lung tumors who were treated using 401 RFA sessions from April 2010 to March 2020 were included. Of which, 31 patients with 38 early enlarging cavitation and control group (151 patients with 228 tumors) were analyzed. Early enlarging cavitation was defined as cavities with an enlarged size (>3 cm) occurring on ablated lesions within seven days after RFA. Incidence of cavitation, risk and post-procedural factors of occurrence, major adverse events (AEs) that occurred in RFA sessions with cavitation, and course of cavitation were evaluated. AEs were classified using the CIRSE classification system for complications. RESULTS: Thirty-eight cavities (6.3%, 38/605 tumors) in 31 patients occurred in an average of 3.1 ± 1.7 days (range, 1-7 days) after 32 RFA sessions. Distance from pleura ≥ 20 mm, contact with vessel ≥ 3 mm, multitined expandable electrode ≥ 3 cm, and bronchus ≥ 2 mm encompassed in the ablation zone were independent risk factors of occurrence. Fever ≥ 38.5 °C, white blood cell count ≥ 10,000/μl one day after RFA, and steroid therapy were independent post-procedural factors of occurrence. Twenty-four Grade 3 and two Grade 6 AEs occurred. Twenty-nine cavities disappeared within a mean duration of 111.9 ± 64.9 (SD) days (range: 44-274 days) and four remained with a mean follow-up of 279.2 ± 174 (SD) days; five patients were lost to follow-up. CONCLUSIONS: Early enlarging cavitation occurs in 6.3% of lung tumors treated with RFA and are associated with 26 major AEs in 32 sessions. Aforementioned procedural factors and post-procedural inflammation were significant risk factors of occurrence.

    DOI: 10.1016/j.diii.2022.05.004

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  • Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation Reviewed International journal

    Kenichi Nakamura, Hitoshi Ozawa, Taro Shibata, Nobuko Ushirozawa, Tomomi Hata, Natsuko Okita, Nozomu Fuse, Norihiro Sato, Koji Ikeda, Hideki Hanaoka, Tatsuya Maruyama, Michihiko Wada, Shinobu Shimizu, Hiroi Kasai, Yoichi Yamamoto, Jun Sakurai, Koji Todaka, Shimon Tashiro, Haruko Yamamoto

    Therapeutic Innovation & Regulatory Science   56 ( 2 )   220 - 229   2021.11

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    <title>Abstract</title><sec>
    <title>Background</title>
    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders.


    </sec><sec>
    <title>Methods</title>
    A total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public.


    </sec><sec>
    <title>Results</title>
    The survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP’s scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data.


    </sec><sec>
    <title>Conclusion</title>
    The recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation.


    </sec>

    DOI: 10.1007/s43441-021-00350-4

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    Other Link: https://link.springer.com/article/10.1007/s43441-021-00350-4/fulltext.html

  • Percutaneous needle biopsy under 1.2 Tesla open MRI guidance Reviewed

    Yusuke Matsui, Takao Hiraki, Jun Sakurai, Soichiro Okamoto, Toshihiro Iguchi, Koji Tomita, Mayu Uka, Takatsugu Yamauchi, Hideo Gobara, Susumu Kanazawa

    Japanese Journal of Radiology   40 ( 4 )   430 - 438   2021.11

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    DOI: 10.1007/s11604-021-01211-8

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  • Percutaneous Cryoablation of Lower Limb Soft-Tissue Venous Malformations: Preliminary Results of Long-Term Efficacy Reviewed

    Hiroyasu Fujiwara, Takao Hiraki, Yusuke Matsui, Mayu Uka, Koji Tomita, Toshihiro Iguchi, Jun Sakurai, Takao Soshi, Hideo Gobara, Susumu Kanazawa

    CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY   44 ( 9 )   1485 - 1490   2021.6

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    Purpose To retrospectively evaluate long-term efficacy of percutaneous cryoablation for lower limb soft-tissue venous malformations. Materials and Methods Nine patients (mean age, 36.6 years) with lower limb soft-tissue venous malformations were included. Cryoablation was performed percutaneously using an argon-based system. Adverse events (AE) using the Common Terminology Criteria for AEs version 4.0 were evaluated. The visual analog scale (VAS) scores and lesion volumes measured on magnetic resonance imaging were also evaluated at 12 months and 5-6 years. Results Technical success (i.e., complete coverage of the lesion by an iceball) was achieved in eight of the nine patients. All patients developed a total of 14 grade 1 or 2 adverse events. The mean (+/- standard deviation) VAS score was 6.0 (+/- 1.7) before therapy, whereas it was 0.14 (+/- 0.27) at 12 months and 0.97 (+/- 1.3) at 5-6 years (58-78 months). Complete pain relief was obtained in 6 and 5 patients at 12 months and 5-6 years, respectively. The median lesion volume was 2.49 mL before therapy, whereas it was 0.26 mL at 12 months and 0.35 mL at 5-6 years. Conclusion Percutaneous cryoablation of lower limb soft-tissue venous malformations achieved considerable pain relief and lesion shrinkage for 5-6 years in this small preliminary study.

    DOI: 10.1007/s00270-021-02876-4

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  • Needle Tract Ablation in Liver Tissue Using a Cryoprobe Combined with an Electrosurgical Device: Influence of ex vivo and in vivo Animal Models. Reviewed

    Hideo Gobara, Akira Yamamoto, Toshiyuki Komaki, Toshiaki Kitayama, Jun Sakurai, Toshihiro Iguchi, Yusuke Matsui, Mayu Uka, Koji Tomita, Takao Hiraki, Susumu Kanazawa

    Acta medica Okayama   75 ( 1 )   9 - 14   2021.2

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    To assess the feasibility of needle tract ablation in liver tissue in ex vivo and in vivo animal models using a cryo-probe and electrosurgical device. The experimental device is made by inserting a cryoprobe through an intro-ducer sheath for insulation, with 2-cm of probe tip projecting out. A beagle liver was punctured by the device, and electric current was applied at 30-W with the electrosurgical knife touching the non-insulated device base. The discolored area of cut surface along the device was evaluated in 5 application-time groups (5 , 10 , 15 , 20, or 25 seconds). An ex vivo experiment was performed to determine an ablation algorithm with an appropriate application time by comparison with radiofrequency ablation (RFA) results. Thereafter, an in vivo experiment was performed to verify the algorithm's feasibility. In the ex vivo model, the cut surface demonstrated different amounts of discolored area according to the application time. The total discolored area in the 20-seconds group was similar to that by RFA. In the in vivo model, the liver did not bleed, the total discolored area was similar to that ex vivo, and coagulation necrosis was confirmed by photomicrograph. Needle tract ablation can be per-formed using the experimental device and electrosurgical device.

    DOI: 10.18926/AMO/61428

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  • Needle artifact characteristics and insertion accuracy using a 1.2T open MRI scanner: A phantom study. Reviewed International journal

    Soichiro Okamoto, Yusuke Matsui, Takao Hiraki, Toshihiro Iguchi, Toshiyuki Komaki, Takatsugu Yamauchi, Mayu Uka, Koji Tomita, Jun Sakurai, Hideo Gobara, Susumu Kanazawa

    Diagnostic and interventional imaging   102 ( 6 )   363 - 370   2021.1

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    PURPOSE: To evaluate the characteristics of needle artifacts and the accuracy of needle insertion using a 1.2 Tesla open magnetic resonance imaging (MRI) system in a phantom. MATERIALS AND METHODS: First, the apparent width of the needle on the MRI and the needle tip position error of 16- and 18-gauge MRI-compatible introducer needles and a 17-gauge cryoneedle were examined with different needle angles (0°, 30°, 45°, 60°, and 90°) to the main magnetic field (B0), sequence types (balanced steady-state acquisition with rewound gradient echo [BASG] and T2-weighted fast spin echo [FSE] sequence), and frequency encoding directions. Second, the accuracy of needle insertion was evaluated after 10 MRI fluoroscopy-guided insertions in a phantom. RESULTS: The apparent needle widths was larger when the angle of the needle axis relative to B0 was larger. The needles appeared larger on BASG than on T2-weighted FSE images, with the largest apparent widths of 16-, 17-, and 18-gauge needles of 14.3, 11.6, and 11.0mm, respectively. The apparent needle tip position was always more distal than the actual position on BASG images, with the largest longitudinal error of 4.0mm. Meanwhile, the 16- and 18-gauge needle tips appeared more proximal on T2-weighted FSE images with right-to-left frequency encoding direction. The mean accuracy of MRI fluoroscopy-guided needle insertion was 3.1mm. CONCLUSION: These experiments clarify the characteristics of needle artifacts in a 1.2 Tesla open MRI. With this system, the MRI fluoroscopy-guided needle insertion demonstrated an acceptable accuracy for clinical use.

    DOI: 10.1016/j.diii.2020.12.007

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  • Oncologic outcomes and safety of percutaneous cryoablation for biopsy-proven renal cell carcinoma up to 4 cm in diameter: a prospective observational study. Reviewed

    Hideo Gobara, Takao Hiraki, Toshihiro Iguchi, Yusuke Matsui, Jun Sakurai, Mayu Uka, Koji Tomita, Toshiyuki Komaki, Yasuyuki Kobayasi, Motoo Araki, Toyohiko Watanabe, Susumu Kanazawa

    International journal of clinical oncology   26 ( 3 )   562 - 568   2020.11

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    BACKGROUND: Percutaneous cryoablation is widely used for the treatment of renal cell carcinoma. We prospectively evaluated the oncologic outcomes and safety of percutaneous cryoablation for the treatment of tumors ≤ 4 cm in diameter. METHODS: We included patients aged ≥ 20 years, who had histologically proven renal cell carcinoma, tumor diameter ≤ 4 cm, a performance status of ≤ 1, acceptable laboratory parameters, were inoperable or refused to undergo surgery, and had signed a written informed consent. The primary endpoint was the cause-specific survival rate. The secondary endpoints were overall and progression-free survival, and adverse event frequency and grade. All procedures were percutaneously performed under computed tomography fluoroscopy guidance. RESULTS: From October 2013 to October 2015, 33 patients (mean age: 68 ± 14 years; sex: six women, 27 men) were enrolled. The mean tumor diameter was 2.1 ± 0.6 (range 1.0-3.4) cm. The median follow-up period was 60.1 (range 18.4-76.6) months. One patient died of non-renal cell carcinoma-related disease 46 months after percutaneous cryoablation. The cause-specific and overall survival rates were 100% and 96.8% at 3 years, and 100% and 96.8% at 5 years, respectively. There was no local tumor progression or distant metastasis. The incidence of severe urological (urinary fistula and perinephric infection) and non-urological adverse events (increased creatine kinase and skin ulceration) was 6% each. CONCLUSION: Percutaneous cryoablation for renal cell carcinoma ≤ 4 cm in diameter achieved good tumor control with a low complication frequency.

    DOI: 10.1007/s10147-020-01825-4

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  • Survival Outcomes of Treatment with Radiofrequency Ablation, Stereotactic Body Radiotherapy, or Sublobar Resection for Patients with Clinical Stage I Non-Small-Cell Lung Cancer: A Single-Center Evaluation. Reviewed International journal

    Toshihiro Iguchi, Takao Hiraki, Yusuke Matsui, Toshiharu Mitsuhashi, Norihisa Katayama, Kuniaki Katsui, Junichi Soh, Jun Sakurai, Hideo Gobara, Shinichi Toyooka, Susumu Kanazawa

    Journal of vascular and interventional radiology : JVIR   31 ( 7 )   1044 - 1051   2020.7

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    PURPOSE: To retrospectively compare the outcomes of radiofrequency (RF) ablation, stereotactic body radiotherapy (SBRT), and sublobar resection (SLR) in patients with stage I non-small-cell lung cancer (NSCLC) at a single center. MATERIALS AND METHODS: Overall, 289 patients (38 RF ablation, 58 SBRT, and 193 SLR) were included. Kaplan-Meier curves were generated, multiple propensity score was estimated using a multinomial logistic regression model, and relationships between treatments and outcomes were assessed using a Cox proportional hazard model. Hazard ratios (HRs) for death from any cause and disease progression or death from any cause were examined by a crude model, an inverse probability of treatment weighting (IPTW) model, and an IPTW model adjusted for missing variables. RESULTS: The 5-year overall and progression-free survival rates were 58.9% and 39.9%, respectively, for RF ablation; 42.0% and 34.9%, respectively, for SBRT; and 85.5% and 75.9%, respectively, for SLR. Significantly longer survival time and lower HR were observed for SLR than other treatments. However, after statistical adjustment, these relationships were not significant except for reduced HR of disease progression or death from any cause of SLR compared to RF ablation in the IPTW model. The median hospital stays for RF ablation, SBRT, and SLR were 6.5, 6, and 16 days, respectively. Adverse events of grade 3 or higher occurred only in 11 SLR cases. CONCLUSIONS: SLR achieved the longest survival. However, after statistical adjustment, there were no significant outcome differences among RF ablation, SBRT, and SLR, except for 1 model. RF ablation or SBRT may be alternative treatments for selected patients with early-stage NSCLC.

    DOI: 10.1016/j.jvir.2019.11.035

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  • A Clinical Study Evaluating an Aspiration-type Semi-Automatic Cutting Biopsy Needle (SCIRO-1702). Reviewed

    Yusuke Matsui, Takao Hiraki, Toshihiro Iguchi, Jun Sakurai, Mayu Uka, Yoshihisa Masaoka, Hideo Gobara, Susumu Kanazawa

    Acta medica Okayama   74 ( 3 )   209 - 214   2020.6

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    An aspiration-type semi-automatic cutting biopsy needle enables tissue cutting during application of negative pressure, which is expected to contribute to a larger amount of specimen. The aim of the present study was to evaluate this novel needle in a clinical setting. Patients who underwent image-guided percutaneous biopsy for lung or renal masses were enrolled. Cutting biopsy was performed with and without aspiration during each procedure. The specimens were weighed using an electronic scale. The weights were compared between specimens obtained with and without aspiration using a paired t-test. The data from 45 lung and 30 renal biopsy procedures were analyzed. In lung biopsy, the mean±standard deviation weights of specimens obtained with and without aspiration were 2.20±1.05 mg and 2.24±1.08 mg, respectively. In renal biopsy, the mean weights were 6.52±2.18 mg and 6.42±1.62 mg, respectively. The weights were not significantly different between specimens obtained with and without aspiration either in lung (p=0.799) or renal (p=0.789) biopsies. The application of negative pressure with the aspiration-type semi-automatic cutting biopsy needle did not contribute to an increase in the amount of the specimen obtained in lung and renal biopsies.

    DOI: 10.18926/AMO/59951

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  • Embolization using hydrogel-coated coils for pulmonary arteriovenous malformations. Reviewed International journal

    T Iguchi, T Hiraki, Y Matsui, H Fujiwara, J Sakurai, K Baba, S Toyooka, H Gobara, S Kanazawa

    Diagnostic and interventional imaging   101 ( 3 )   129 - 135   2020.3

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    PURPOSE: To prospectively evaluate the efficacy and safety of embolization using hydrogel-coated coils for the treatment of pulmonary arteriovenous malformations (PAVMs). MATERIALS AND METHODS: The outcomes of 21 PAVMs in 19 patients (3 men and 16 women; mean age, 58.8±15.2 [SD] years; age range 14-78 years) treated by venous sac embolization (VSE) with additional feeding artery embolization were prospectively evaluated. For VSE, using one or more 0.018-inch hydrogel-coated coils was mandatory. Recanalization and/or reperfusion were evaluated by pulmonary arteriography 1 year after embolization. RESULTS: The mean feeding artery and venous sac sizes were 4.0mm and 8.5mm, respectively. Embolization was successfully completed in 20/21 PAVMs, yielding a technical success rate of 95%. The feeding artery was also embolized in 17/20 successful PAVMs (85%). A technical failure occurred in one PAVM, where embolization was abandoned because of migration of one bare coil to the left ventricle. The mean numbers of hydrogel-coated coils and bare platinum detachable coils used for VSE were 3.3±2.1 (SD) (range, 1-8) and 4.4±3.9 (SD) (range, 1-17), respectively. The mean percentages of hydrogel-coated coils in number, length, and estimated volume were 42.9%, 33.3%, and 72.7% respectively. One patient with one PAVM was lost to follow-up after 3 months. Neither recanalization nor reperfusion was noted in the remaining 19 PAVMs (success rate, 19/19 [100%]). One grade 4 (coil migration) adverse event occurred, and it was treated without any sequelae. CONCLUSION: VSE using hydrogel-coated coils with additional feeding artery embolization is a safe and effective treatment for PAVM.

    DOI: 10.1016/j.diii.2019.10.008

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  • Robotic CT-guided out-of-plane needle insertion: comparison of angle accuracy with manual insertion in phantom and measurement of distance accuracy in animals. Reviewed International journal

    Toshiyuki Komaki, Takao Hiraki, Tetsushi Kamegawa, Takayuki Matsuno, Jun Sakurai, Ryutaro Matsuura, Takuya Yamaguchi, Takanori Sasaki, Toshiharu Mitsuhashi, Soichiro Okamoto, Mayu Uka, Yusuke Matsui, Toshihiro Iguchi, Hideo Gobara, Susumu Kanazawa

    European radiology   30 ( 3 )   1342 - 1349   2020.3

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    OBJECTIVES: To evaluate the accuracy of robotic CT-guided out-of-plane needle insertion in phantom and animal experiments. METHODS: A robotic system (Zerobot), developed at our institution, was used for needle insertion. In the phantom experiment, 12 robotic needle insertions into a phantom at various angles in the XY and YZ planes were performed, and the same insertions were manually performed freehand, as well as guided by a smartphone application (SmartPuncture). Angle errors were compared between the robotic and smartphone-guided manual insertions using Student's t test. In the animal experiment, 6 robotic out-of-plane needle insertions toward targets of 1.0 mm in diameter placed in the kidneys and hip muscles of swine were performed, each with and without adjustment of needle orientation based on reconstructed CT images during insertion. Distance accuracy was calculated as the distance between the needle tip and the target center. RESULTS: In the phantom experiment, the mean angle errors of the robotic, freehand manual, and smartphone-guided manual insertions were 0.4°, 7.0°, and 3.7° in the XY plane and 0.6°, 6.3°, and 0.6° in the YZ plane, respectively. Robotic insertions in the XY plane were significantly (p < 0.001) more accurate than smartphone-guided insertions. In the animal experiment, the overall mean distance accuracy of robotic insertions with and without adjustment of needle orientation was 2.5 mm and 5.0 mm, respectively. CONCLUSION: Robotic CT-guided out-of-plane needle insertions were more accurate than smartphone-guided manual insertions in the phantom and were also accurate in the in vivo procedure, particularly with adjustment during insertion. KEY POINTS: • Out-of-plane needle insertions performed using our robot were more accurate than smartphone-guided manual insertions in the phantom experiment and were also accurate in the in vivo procedure. • In the phantom experiment, the mean angle errors of the robotic and smartphone-guided manual out-of-plane needle insertions were 0.4° and 3.7° in the XY plane (p < 0.001) and 0.6° and 0.6° in the YZ plane (p = 0.65), respectively. • In the animal experiment, the overall mean distance accuracies of the robotic out-of-plane needle insertions with and without adjustments of needle orientation during insertion were 2.5 mm and 5.0 mm, respectively.

    DOI: 10.1007/s00330-019-06477-1

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  • Robotic needle insertion during computed tomography fluoroscopy-guided biopsy: prospective first-in-human feasibility trial. Reviewed International journal

    Takao Hiraki, Tetsushi Kamegawa, Takayuki Matsuno, Jun Sakurai, Toshiyuki Komaki, Takuya Yamaguchi, Koji Tomita, Mayu Uka, Yusuke Matsui, Toshihiro Iguchi, Hideo Gobara, Susumu Kanazawa

    European radiology   30 ( 2 )   927 - 933   2020.2

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    INTRODUCTION: This was a prospective, first-in-human trial to evaluate the feasibility and safety of insertion of biopsy introducer needles with our robot during CT fluoroscopy-guided biopsy in humans. MATERIALS AND METHODS: Eligible patients were adults with a lesion ≥ 10 mm in an extremity or the trunk requiring pathological diagnosis with CT fluoroscopy-guided biopsy. Patients in whom at-risk structures were located within 10 mm of the scheduled needle tract were excluded. Ten patients (4 females and 6 males; mean [range] age, 72 [52-87] years) with lesions (mean [range] maximum diameter, 28 [14-52] mm) in the kidney (n = 4), lung (n = 3), mediastinum (n = 1), adrenal gland (n = 1), and muscle (n = 1) were enrolled. The biopsy procedure involved robotic insertion of a biopsy introducer needle followed by manual acquisition of specimens using a biopsy needle. The patients were followed up for 14 days. Feasibility was defined as the distance of ≤ 10 mm between needle tip after insertion and the nearest lesion edge on the CT fluoroscopic images. The safety of robotic insertion was evaluated on the basis of machine-related troubles and adverse events according to the Clavien-Dindo classification. RESULTS: Robotic insertion of the introducer needle was feasible in all patients, enabling pathological diagnosis. There was no machine-related trouble. A total of 11 adverse events occurred in 8 patients, including 10 grade I events and 1 grade IIIa event. CONCLUSION: Insertion of biopsy introducer needles with our robot was feasible at several locations in the human body. KEY POINTS: • Insertion of biopsy introducer needles with our robot during CT fluoroscopy-guided biopsy was feasible at several locations in the human body.

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  • Post-ablation syndrome after percutaneous cryoablation of small renal tumors: A prospective study of incidence, severity, duration, and effect on lifestyle. Reviewed International journal

    Takahiro Kawabata, Takao Hiraki, Toshihiro Iguchi, Yusuke Matsui, Mayu Uka, Yoshihisa Masaoka, Toshiyuki Komaki, Jun Sakurai, Hideo Gobara, Motoo Araki, Yasutomo Nasu, Susumu Kanazawa

    European journal of radiology   122   108750 - 108750   2020.1

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    PURPOSE: To prospectively investigate the incidence, severity, duration, and effect on lifestyle of post-ablation syndrome (PAS) after percutaneous renal cryoablation. MATERIALS AND METHODS: We enrolled 39 patients (27 male and 12 female; mean age, 62 years) who underwent 40 CT-guided cryoablation sessions for pathologically proven renal cancer (mean size, 20 mm) between December 2015 and December 2017. Four symptoms attributable to PAS, i.e., fever, nausea, vomiting, malaise, and the synergistic effect of these symptoms on lifestyle by 21 days after ablation were evaluated using a questionnaire. Symptoms were graded according to the common toxicity criteria of adverse events. RESULTS: The incidences of fever, nausea, vomiting, and malaise were 100% (40/40), 20% (8/40), 20% (8/40), and 63% (25/40), respectively. Most (78/81, 96%) symptoms had begun by day 2. The highest grade of fever per session was 0 (defined as ≥37.0 °C and <38.0 °C) (n = 24), 1 (n = 15), or 2 (n = 1); that of nausea was 2 (n = 8); that of vomiting was 1 (n = 7) or 3 (n = 1); and that of malaise was 1 (n = 14) or 2 (n = 11). Most (76/81, 94%) symptoms had resolved by day 8. The average values for the maximum scores of interference with general activity and work were 3.6 and 1.1, respectively. CONCLUSION: All symptoms were generally early-onset and self-limiting, with minimal impact on lifestyle and resolution by day 8. The clinical course and impact of PAS should be acknowledged by practitioners who manage patients undergoing renal cryoablation.

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  • Radiofrequency Ablation for Stage I Non-Small Cell Lung Cancer: An Updated Review of Literature from the Last Decade Reviewed International journal

    Yusuke Matsui, Toshihiro Iguchi, Koji Tomita, Mayu Uka, Jun Sakurai, Hideo Gobara, Susumu Kanazawa

    Interventional Radiology   5 ( 2 )   43 - 49   2020

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  • Reversible phrenic nerve injury after radiofrequency ablation of lung tumor. Reviewed International journal

    T Iguchi, T Hiraki, Y Matsui, J Sakurai, S Kanazawa

    Diagnostic and interventional imaging   100 ( 11 )   725 - 727   2019.11

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  • MRI-guided percutaneous needle biopsy with 1.2T open MRI: study protocol for a prospective feasibility study (SCIRO-1701). Reviewed

    Yusuke Matsui, Jun Sakurai, Takao Hiraki, Soichiro Okamoto, Toshihiro Iguchi, Koji Tomita, Mayu Uka, Hideo Gobara, Susumu Kanazawa

    Nagoya journal of medical science   81 ( 3 )   463 - 468   2019.8

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    There has been growing interest in magnetic resonance imaging (MRI)-guided interventional procedures such as percutaneous needle biopsy. Although open MRI is preferable for MRI-guided procedures in terms of patient accessibility, its inferior imaging capability due to lower field strength is a substantial limitation. In this situation, the high-field (1.2T) open MRI has recently become available. This novel MRI system is expected to provide excellent image quality as well as good patient accessibility, potentially contributing to safe and accurate device manipulation. This trial is designed to investigate the feasibility of MRI-guided percutaneous needle biopsy with this system. Patients with lesions needing percutaneous needle biopsy for pathological diagnosis are included. The enrollment of ten patients is intended. The primary endpoint of this study is the feasibility of biopsy needle insertion under real-time MR-fluoroscopy guidance based on the presence of the notch of the biopsy needle within the target lesion. The secondary endpoints are adverse events, device failures, and success of specimen acquisition. Once the feasibility of MRI-guided biopsy with 1.2T open MRI is validated by this study, it may potentially encourage widespread use of MRI-guidance for biopsy procedures. Furthermore, it may lead to development of the other MRI-guided interventional procedures using this MRI system.

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  • Zerobot®: A Remote-controlled Robot for Needle Insertion in CT-guided Interventional Radiology Developed at Okayama University. Reviewed

    Takao Hiraki, Tetsushi Kamegawa, Takayuki Matsuno, Toshiyuki Komaki, Jun Sakurai, Susumu Kanazawa

    Acta medica Okayama   72 ( 6 )   539 - 546   2018.12

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    Since 2012, we have been developing a remote-controlled robotic system (Zerobot®) for needle insertion during computed tomography (CT)-guided interventional procedures, such as ablation, biopsy, and drainage. The system was designed via a collaboration between the medical and engineering departments at Okayama University, including various risk control features. It consists of a robot with 6 degrees of freedom that is manipulated using an operation interface to perform needle insertions under CT-guidance. The procedure includes robot positioning, needle targeting, and needle insertion. Phantom experiments have indicated that robotic insertion is equivalent in accuracy to manual insertion, without physician radiation exposure. Animal experiments have revealed that robotic insertion of biopsy introducer needles and various ablation needles is safe and accurate in vivo. The first in vivo human trial, therefore, began in April 2018. After its completion, a larger clinical study will be conducted for commercialization of the robot. This robotic procedure has many potential advantages over a manual procedure: 1) decreased physician fatigue; 2) stable and accurate needle posture without tremor; 3) procedure automation; 4) less experience required for proficiency in needle insertion skills; 5) decreased variance in technical skills among physicians; and 6) increased likelihood of performing the procedure at remote hospitals (i.e., telemedicine).

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  • Robotic Insertion of Various Ablation Needles Under Computed Tomography Guidance: Accuracy in Animal Experiments Reviewed

    Takao Hiraki, Takayuki Matsuno, Tetsushi Kamegawa, Toshiyuki Komaki, Jun Sakurai, Ryutaro Matsuura, Takuya Yamaguchi, Takanori Sasaki, Toshihiro Iguchi, Yusuke Matsui, Hideo Gobara, Susumu Kanazawa

    European Journal of Radiology   105   162 - 167   2018.8

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    Objective: To evaluate the accuracy of robotic insertion of various ablation needles at various locations under computed tomography (CT) guidance in swine. Materials and methods: The robot was used for CT-guided insertion of four ablation needles, namely a single internally cooled radiofrequency ablation (RFA) needle (Cool-tip), a multi-tined expandable RFA needle (LeVeen), a cryoablation needle (IceRod), and an internally cooled microwave ablation needle (Emprint). One author remotely operated the robot with the operation interface in order to orient and insert the needles under CT guidance. Five insertions of each type of ablation needle towards 1.0-mm targets in the liver, kidney, lung, and hip muscle were attempted on the plane of an axial CT image in six swine. Accuracy of needle insertion was evaluated as the three-dimensional length between the target centre and needle tip. The accuracy of needle insertion was compared according to the type of needle used and the location using one-way analysis of variance. Results: The overall mean accuracy of all four needles in all four locations was 2.8 mm. The mean accuracy of insertion of the Cool-tip needle, LeVeen needle, IceRod needle, and Emprint needle was 2.8 mm, 3.1 mm, 2.5 mm, and 2.7 mm, respectively. The mean accuracy of insertion into the liver, kidney, lung, and hip muscle was 2.7 mm, 2.9 mm, 2.9 mm, and 2.5 mm, respectively. There was no significant difference in insertion accuracy among the needles (P =.38) or the locations (P =.53). Conclusion: Robotic insertion of various ablation needles under CT guidance was accurate regardless of type of needle or location in swine.

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  • Visual Evoked Potential Recovery by Subretinal Implantation of Photoelectric Dye-Coupled Thin Film Retinal Prosthesis in Monkey Eyes With Macular Degeneration. Reviewed

    Matsuo T, Uchida T, Sakurai J, Yamashita K, Matsuo C, Araki T, Yamashita Y, Kamikawa K

    Artificial organs   42 ( 8 )   E186 - E203   2018.8

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    Retinal prosthesis or artificial retina is a promising modality of treatment for outer retinal degeneration, caused by primary and secondary loss of photoreceptor cells, in hereditary retinal dystrophy and age-related macular degeneration, respectively. Okayama University-type retinal prosthesis (OUReP) is a photoelectric dye-coupled polyethylene film which generates electric potential in response to light and stimulates nearby neurons. The dyecoupled films were implanted by vitreous surgery in the subretinal space of monkey eyes with macular degeneration which had been induced by cobalt chloride injection from the scleral side. A pilot 1-month observation study involved 6 monkeys and a pivotal 6-month observation study involved 8 monkeys. Of 8 monkeys in 6-month group, 3 monkeys underwent dye-coupled film removal at 5 months and were observed further for 1 month. The amplitude of visual evoked potential which had been reduced by macular degeneration did recover at 1 month after film implantation and maintained the level at 6 months. Optical coherence tomography showed no retinal detachment, and full-field electroretinograms maintained a-wave and b-wave amplitudes, indicative of no retinal toxicity. Pathological examinations after 6-month implantation showed structural integrity of the inner retinal layer in close apposition to dye-coupled films. The implanted films which were removed by vitrectomy 5 months later showed light-evoked surface electric potentials by scanning Kelvin probe measurement. The photoelectric dye-coupled film (OUReP), which serves as a light-receiver and a displacement current generator in the subretinal space of the eye, has a potential for recovering vision in diseases with photoreceptor cell loss, such as retinitis pigmentosa and age-related macular degeneration.

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  • CT fluoroscopy-guided core needle biopsy of anterior mediastinal masses Reviewed

    T. Iguchi, T. Hiraki, Y. Matsui, H. Fujiwara, J. Sakurai, Y. Masaoka, M. Uka, T. Tanaka, H. Gobara, S. Kanazawa

    Diagnostic and Interventional Imaging   99 ( 2 )   91 - 97   2018.2

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    Objective: To retrospectively evaluate the safety, diagnostic yield, and risk factors of diagnostic failure of computed tomography (CT) fluoroscopy-guided biopsies of anterior mediastinal masses. Materials and methods: Biopsy procedures and results of anterior mediastinal masses in 71 patients (32 women/39 men
    mean [± standard deviation] age, 53.8 ± 20.0 years
    range, 14–88 years) were analyzed. Final diagnoses were based on surgical outcomes, imaging findings, or clinical follow-up findings. The biopsy results were compared with the final diagnosis, and the biopsy procedures grouped by pathologic findings into diagnostic success and failure groups. Multiple putative risk factors for diagnostic failure were then assessed. Results: Seventy-one biopsies (71 masses
    mean size, 67.5 ± 27.3 mm
    range 8.6–128.2 mm) were analyzed. We identified 17 grade 1 and one grade 2 adverse events (25.4% overall) according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Sixty-nine biopsies (97.2%) provided samples fit for pathologic analysis. Diagnostic failure was found for eight (11.3%) masses
    the 63 masses diagnosed successfully included thymic carcinoma (n = 17), lung cancer (n = 14), thymoma (n = 12), malignant lymphoma (n = 11), germ cell tumor (n = 3), and others (n = 6). Using a thinner needle (i.e., a 20-gauge needle) was the sole significant risk factor for diagnostic failure (P = 0.039). Conclusion: CT fluoroscopy-guided biopsy of anterior mediastinal masses was safe and had a high diagnostic yield
    however, using a thinner biopsy needle significantly increased the risk of a failed diagnosis.

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  • CT fluoroscopy-guided renal tumour cutting needle biopsy: retrospective evaluation of diagnostic yield, safety, and risk factors for diagnostic failure Reviewed

    Toshihiro Iguchi, Takao Hiraki, Yusuke Matsui, Hiroyasu Fujiwara, Jun Sakurai, Yoshihisa Masaoka, Hideo Gobara, Susumu Kanazawa

    EUROPEAN RADIOLOGY   28 ( 1 )   283 - 290   2018.1

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    To evaluate retrospectively the diagnostic yield, safety, and risk factors for diagnostic failure of computed tomography (CT) fluoroscopy-guided renal tumour biopsy.
    Biopsies were performed for 208 tumours (mean diameter 2.3 cm; median diameter 2.1 cm; range 0.9-8.5 cm) in 199 patients. One hundred and ninety-nine tumours were ae&lt;currency&gt;4 cm. All 208 initial procedures were divided into diagnostic success and failure groups. Multiple variables related to the patients, lesions, and procedures were assessed to determine the risk factors for diagnostic failure.
    After performing 208 initial and nine repeat biopsies, 180 malignancies and 15 benign tumours were pathologically diagnosed, whereas 13 were not diagnosed. In 117 procedures, 118 Grade I and one Grade IIIa adverse events (AEs) occurred. Neither Grade ae&lt;yen&gt;IIIb AEs nor tumour seeding were observed within a median follow-up period of 13.7 months. Logistic regression analysis revealed only small tumour size (ae&lt;currency&gt;1.5 cm; odds ratio 3.750; 95% confidence interval 1.362-10.326; P = 0.011) to be a significant risk factor for diagnostic failure.
    CT fluoroscopy-guided renal tumour biopsy is a safe procedure with a high diagnostic yield. A small tumour size (ae&lt;currency&gt;1.5 cm) is a significant risk factor for diagnostic failure.
    aEuro cent CT fluoroscopy-guided renal tumour biopsy has a high diagnostic yield.
    aEuro cent CT fluoroscopy-guided renal tumour biopsy is safe.
    aEuro cent Small tumour size (ae&lt;currency&gt;1.5 cm) is a risk factor for diagnostic failure.

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  • Robotically Driven CT-guided Needle Insertion: Preliminary Results in Phantom and Animal Experiments Reviewed

    Takao Hiraki, Tetsushi Kamegawa, Takayuki Matsuno, Jun Sakurai, Yasuzo Kirita, Ryutaro Matsuura, Takuya Yamaguchi, Takanori Sasaki, Toshiharu Mitsuhashi, Toshiyuki Komaki, Yoshihisa Masaoka, Yusuke Matsui, Hiroyasu Fujiwara, Toshihiro Iguchi, Hideo Gobara, Susumu Kanazawa

    RADIOLOGY   285 ( 2 )   454 - 461   2017.11

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    Purpose: To evaluate the accuracy of the remote-controlled robotic computed tomography (CT)-guided needle insertion in phantom and animal experiments.
    Materials and Methods: In a phantom experiment, 18 robotic and manual insertions each were performed with 19-gauge needles by using CT fluoroscopic guidance for the evaluation of the equivalence of accuracy of insertion between the two groups with a 1.0-mm margin. Needle insertion time, CT fluoroscopy time, and radiation exposure were compared by using the Student t test. The animal experiments were approved by the institutional animal care and use committee. In the animal experiment, five robotic insertions each were attempted toward targets in the liver, kidneys, lungs, and hip muscle of three swine by using 19-gauge or 17-gauge needles and by using conventional CT guidance. The feasibility, safety, and accuracy of robotic insertion were evaluated.
    Results: The mean accuracies of robotic and manual insertion in phantoms were 1.6 and 1.4 mm, respectively. The 95% confidence interval of the mean difference was 20.3 to 0.6 mm. There were no significant differences in needle insertion time, CT fluoroscopy time, or radiation exposure to the phantom between the two methods. Effective dose to the physician during robotic insertion was always 0 mSv, while that during manual insertion was 5.7 mSv on average (P&lt;.001). Robotic insertion was feasible in the animals, with an overall mean accuracy of 3.2 mm and three minor procedure-related complications.
    Conclusion: Robotic insertion exhibited equivalent accuracy as manual insertion in phantoms, without radiation exposure to the physician. It was also found to be accurate in an in vivo procedure in animals. (C) RSNA, 2017

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  • Radiofrequency ablation of pulmonary tumors near the diaphragm Reviewed International journal

    T. Iguchi, T. Hiraki, H. Gobara, H. Fujiwara, J. Sakurai, Y. Matsui, T. Mitsuhashi, S. Toyooka, S. Kanazawa

    DIAGNOSTIC AND INTERVENTIONAL IMAGING   98 ( 7-8 )   535 - 541   2017.7

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    Purpose: To retrospectively evaluate the feasibility, safety, and efficacy of radiofrequency ablation (RFA) of lung tumors located near the diaphragm.
    Materials and methods: A total of 26 patients (15 men, 11 women; mean age, 61.5 years +/- 13.0 [SD]) with a total of 29 lung tumors near the diaphragm (i.e., distance &lt; 10 mm) were included. Mean tumor diameter was 11.0 mm +/- 5.3 (SD) (range, 2-23 mm). Efficacy of RFA, number of adverse events and number of adverse events with a grade &gt;= 3, based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0, were compared between patients with lung tumors near the diaphragm and a control group of patients with more distally located lung tumors (i.e., distance &gt;= 10 mm).
    Results: RFA was technically feasible for all tumors near the diaphragm. Four grade 3 adverse events (1 pneumothorax requiring pleurodesis and 3 phrenic nerve injuries) were observed. No grade &gt;= 4 adverse events were reported. The median follow-up period for tumors near the diaphragm was 18.3 months. Local progression was observed 3.3 months after RFA in 1 tumor. The technique efficacy rates were 96.2% at 1 year and 96.2% at 2 years and were not different, from those observed in control subjects (186 tumors; P = 0.839). Shoulder pain (P &lt; 0.001) and grade 1 pleural effusion (P &lt; 0.001) were more frequently observed in patients with lung tumor near the diaphragm. The rates of grade &gt;= 3 adverse events did not significantly differ between tumors near the diaphragm (4/26 sessions) and the controls (7/133 sessions) (P = 0.083).
    Conclusion: RFA is a feasible and effective therapeutic option for lung tumors located near the diaphragm. However, it conveys a higher rate of shoulder pain and asymptomatic pleural effusion by comparison with more distant lung tumors. (C) 2017 Editions francaises de radiologie. Published by Elsevier Masson SAS. All rights reserved.

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  • Disappearance of Renal Cysts Included in Ice Ball During Cryoablation of Renal-Cell Carcinoma: A Potential Therapy for Symptomatic Renal Cysts? Reviewed

    Mitsuko Yodoya, Takao Hiraki, Toshihiro Iguchi, Hiroyasu Fujiwara, Yusuke Matsui, Yoshihisa Masaoka, Jun Sakurai, Toshiharu Mitsuhashi, Hideo Gobara, Susumu Kanazawa

    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY   28 ( 6 )   869 - 876   2017.6

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    Purpose: To retrospectively evaluate the effect of cryoablation of renal-cell carcinoma on nearby renal cysts with the goal to investigate the potential for an alternative therapy to treat symptomatic renal cysts.
    Materials and Methods: The study population comprised 46 cysts (mean size, 12 mm; range, 5-43 mm) that were within or near the ice ball during cryoablation in 22 patients. Size change of each cyst was evaluated via enhanced CT or MR imaging before and 1, 3, 6, and 12 months after cryoablation. Forty-one cysts were also followed after 12 months. Variables including positional relationship between the cyst and the ice ball were evaluated via linear regression analysis using generalized estimating equation models to determine which factors affected cyst shrinkage rate at 12 months.
    Results: Fifteen, 12, and 19 cysts were completely included in, partially included in, or excluded from the ice ball, respectively. The overall shrinkage rate was 62%, and 57% of cysts (26 of 46) had disappeared at 12 months. Only the relationship between the cyst and the ice ball was significantly (P &lt; .001) associated with cyst shrinkage rate. Cyst disappearance rates at 12 months were 100% (15 of 15), 67% (8 of 12), and 16% (3 of 19) for cysts completely included, partially included, and excluded from the ice ball, respectively: Among the 22 cysts that disappeared at 12 months and continued to be followed, none recurred after 12 months.
    Conclusions: All renal cysts that were completely included in the ice ball disappeared after cryoablation, demonstrating the potential utility of cryoablation as an alternative therapy for symptomatic renal cysts.

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  • Radiofrequency ablation of pulmonary metastases from sarcoma: single-center retrospective evaluation of 46 patients Reviewed

    Takuya Sato, Toshihiro Iguchi, Takao Hiraki, Hideo Gobara, Hiroyasu Fujiwara, Jun Sakurai, Yusuke Matsui, Toshiharu Mitsuhashi, Junichi Soh, Shinichi Toyooka, Susumu Kanazawa

    JAPANESE JOURNAL OF RADIOLOGY   35 ( 2 )   61 - 67   2017.2

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    This retrospective, single-center study evaluated radiofrequency (RF) ablation for pulmonary metastases of sarcoma.
    Forty-six patients with sarcoma (144 pulmonary metastases) underwent 88 RF ablation sessions. Data regarding local tumor progression, efficacy, procedural adverse events (AEs; National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0), overall survival (OS), and OS-associated prognostic factors were retrospectively evaluated using univariate analyses.
    Local progression occurred in 22 of 144 tumors (15.3%). Primary and secondary efficacy rates were 83.5 and 90.0% at 1 year and 76.3 and 81.4% at 2 years, respectively. Seventy-three grade 1 AEs, 33 grade 2 AEs, and no grade &gt;= 3 AEs were observed. Twenty-eight patients (60.9%) remained alive and 18 died, yielding 1-, 2-, and 3-year OS rates of 80.6, 70.1, and 47.1% (median survival time, 31.7 months). Univariate analysis revealed extrapulmonary metastasis (P = 0.005), noncurative RF ablation (P = 0.009), and a post-RF ablation disease-free interval of &lt;= 12 months (P = 0.015) as significant negative prognostic factors.
    RF ablation is safe, offers good local control, and may be a viable treatment option for pulmonary metastasis of sarcoma.

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  • Value of percutaneous needle biopsy of small renal tumors in patients referred for cryoablation Reviewed

    Toshihiro Iguchi, Takao Hiraki, Hideo Gobara, Hiroyasu Fujiwara, Jun Sakurai, Yusuke Matsui, Motoo Araki, Yasutomo Nasu, Susumu Kanazawa

    MINIMALLY INVASIVE THERAPY & ALLIED TECHNOLOGIES   26 ( 2 )   86 - 91   2017

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    Purpose: To retrospectively evaluate the safety and diagnostic yield of needle biopsy of small renal tumors, and the clinical consequences of performing needle biopsy in patients referred for percutaneous cryoablation before their treatment.
    Material and methods: Biopsy was performed for 120 tumors (mean diameter, 2.2 cm) in 119 patients. All procedures were divided into diagnostic and non-diagnostic biopsies. Various variables were compared between the two groups. All cryoablation procedures were divided into two groups: procedures with or without simultaneous biopsy. The rates of benign or non-diagnostic tumors in each group were compared.
    Results: After performing 120 initial and eight repeat biopsies, Grade 1 bleedings occurred in 44 cases. Six tumors were non-diagnostic and 114 were pathologically diagnosed. There were no significant variables between the diagnostic and non-diagnostic biopsies. Unnecessary cryoablation was avoided in nine benign lesions by performing biopsy in advance. Cryoablation performed simultaneously with biopsy included significantly more benign or non-diagnostic tumors than cryoablation performed after biopsy (15.2% vs. 1.4%; p =.01).
    Conclusions: Percutaneous biopsy of small renal tumors referred for cryoablation was a safe procedure with high diagnostic yield. The confirmation of pathological diagnosis prior to cryoablation is necessary because patients with benign tumors can avoid unnecessary treatment.

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  • Needle Tract Seeding after Percutaneous Cryoablation of a Metastatic Hepatic Tumor from Renal Cell Carcinoma: A Case Report Reviewed International journal

    Hideo Gobara, Toshiyuki Komaki, Toshihiro Iguchi, Hiroyasu Fujiwara, Jun Sakurai, Yusuke Matsui, Mayu Uka, Yoshihisa Masaoka, Yuzo Umeda, Takao Hiraki, Susumu Kanazawa

    Interventional Radiology   2 ( 3 )   104 - 107   2017

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  • A Case of Solitary Metastasis from a Hepatocellular Carcinoma to the Sacral Bone Successfully Treated with Percutaneous Cryoablation Reviewed

    Noriyuki Umakoshi, Hideo Gobara, Takao Hiraki, Toshihiro Iguchi, Hiroyasu Fujiwara, Jun Sakurai, Yusuke Matsui, Yoshihisa Masaoka, Hiroki Ihara, Toshiaki Wada, Tomonori Seno, Susumu Kanazawa

    Interventional Radiology   2 ( 1 )   14 - 18   2017

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  • Simultaneous biopsy and radiofrequency ablation of T1a renal cell carcinoma Reviewed International journal

    T. Iguchi, T. Hiraki, K. Tomita, H. Gobara, H. Fujiwara, J. Sakurai, Y. Matsui, S. Kanazawa

    DIAGNOSTIC AND INTERVENTIONAL IMAGING   97 ( 11 )   1159 - 1164   2016.11

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    Objective: The goal of this study was to retrospectively evaluate the outcome, including feasibility, safety, diagnostic yield, and factors affecting the success of computed tomography fluoroscopy-guided biopsy when performed during the same procedure than radiofrequency ablation (RFA) in renal tumors strongly suspected of being T1a renal cell carcinoma (RCC).
    Materials and methods: Nineteen patients (13 men, 6 women; mean age, 66.7 years) with a total of 19 suspected renal tumors (mean diameter, 1.8 cm) underwent computed tomography fluoroscopy-guided biopsy during (n = 6) or immediately after (n = 13) RFA. All patients were strongly suspected of having RCC on the basis of patient's medical histories and/or the results of imaging investigations. All procedures were divided into diagnostic and non-diagnostic biopsies. Various variables were compared between the 2 groups using univariate analysis.
    Results: In all tumors, biopsy procedures were technically feasible. No major complications were observed, except for 8 minor post-procedural bleedings. All but one tumor was completely ablated. Local recurrence in the ablation zone as well as tumor seeding in retroperitoneal fat occurred in 1 patient 8.5 months after the procedure and were successfully treated with further percutaneous cryoablation. Thirteen tumors were diagnosed as RCC, whereas 6 were ultimately found to contain normal renal tissue (n = 5) or connective tissue (n = 1). Univariate analysis revealed that none of the variables were significantly different between the diagnostic and non-diagnostic biopsies.
    Conclusion: The performance of renal tumor biopsy and RFA in the same session is feasible and safe. Although pre-treatment pathological diagnosis would be generally desirable, simultaneous biopsy with RFA can be an option for the patients who are not amenable to pre-treatment biopsy. (C) 2016 Editions francaises de radiologie. Published by Elsevier Masson SAS. All rights reserved.

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  • Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502) Reviewed

    Toshihiro Iguchi, Jun Sakurai, Takao Hiraki, Hideo Gobara, Hiroyasu Fujiwara, Yusuke Matsui, Yoshihisa Masaoka, Susumu Kanazawa

    ACTA MEDICA OKAYAMA   70 ( 4 )   303 - 306   2016.8

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    This single center prospective study is being conducted to evaluate the safety of the cryoablation for patients with pathologically diagnosed painful bone and soft tissue tumors. Enrollment of 10 patients is planned over the 3-year recruitment period. Patients have related local pain after receiving medications or external radiation therapies will be included in this study. Cryoablation will be percutaneously performed under imaging guidance, and a temperature sensor will be used during treatment as necessary. The primary endpoint is prevalence of severe adverse events within 4 weeks after therapy. The secondary endpoint is effectiveness 4 weeks after the procedure.

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  • Single Center Prospective Phase II Trial of CT-guided Radiofrequency Ablation for Pulmonary Metastases from Colorectal Cancer (SCIRO-1401) Reviewed

    Jun Sakurai, Yusuke Matsui, Takao Hiraki, Toshihiro Iguchi, Hiroyasu Fujiwara, Hideo Gobara, Toshiharu Mitsuhashi, Takeshi Nagasaka, Susumu Kanazawa

    ACTA MEDICA OKAYAMA   70 ( 4 )   317 - 321   2016.8

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    The present single center prospective phase II clinical trial is designed to evaluate the efficacy and safety of percutaneous radiofrequency (RF) ablation for colorectal lung metastases. Patients who have colorectal lung metastases without extrapulmonary metastases are included in this study. The primary endpoint is 3-year overall survival (OS) after RF ablation. The secondary endpoints are the prevalence of adverse events within 4 weeks, local tumor progression rate, 1- and 5-year OS, cause-specific survival, and relapse-free survival. The recruitment of patients commenced in July 2014, and the enrolment of 45 patients is intended over the 3 years of study period.

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  • Radiofrequency Ablation of Lung Cancer at Okayama University Hospital: A Review of 10 Years of Experience Reviewed

    Takao Hiraki, Hideo Gobara, Hidefumi Mimura, Shinichi Toyooka, Hiroyasu Fujiwara, Kotaro Yasui, Yoshifumi Sano, Toshihiro Iguchi, Jun Sakurai, Nobuhisa Tajiri, Takashi Mukai, Yusuke Matsui, Susumu Kanazawa

    ACTA MEDICA OKAYAMA   65 ( 5 )   287 - 297   2011.10

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    The application of radiofrequency ablation for the treatment of lung cancer by our group at Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences began in June 2001, and in the present report, we review our 10-year experience with this treatment modality at Okayama University Hospital. The local efficacy of radiofrequency ablation for the treatment of lung cancer depends on tumor size and the type of electrode used, but not on tumor type. An important factor for the prevention of local failure may be the acquisition of an adequate ablative margin. The combination of embolization and radiation therapy enhances the local efficacy. Local failure may be salvaged by repeating the radiofrequency ablation, particularly in small tumors. Survival rates after radiofrequency ablation are quite promising for patients with clinical stage I non-small cell lung cancer and pulmonary metastasis from colorectal cancer, hepatocellular carcinoma, and renal cell carcinoma. The complications caused by radiofrequency ablation can be treated conservatively in the majority of cases. However, attention should be paid to rare but serious complications. This review shows that radiofrequency ablation is a promising treatment for patients with lung cancer.

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  • Pulmonary Artery Pseudoaneurysm Related to Radiofrequency Ablation of Lung Tumor Reviewed

    Jun Sakurai, Hidefumi Mimura, Hideo Gobara, Takao Hiraki, Susumu Kanazawa

    CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY   33 ( 2 )   413 - 416   2010.4

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    We describe a case of pulmonary artery (PA) pseudoaneurysm related to radiofrequency ablation (RFA) of lung tumor. We performed RFA for a pulmonary epithelioid hemangioendothelioma directly adjacent to a branch of the PA. Seventeen days later, the patient complained of hemoptysis. A chest CT image revealed PA pseudoaneurysm. Transcatheter coil embolization was performed 59 days after RFA. Although PA pseudoaneurysm is rare, with an incidence of 0.2% (1/538 sessions) at our institution, it should be recognized as a risk when treating lung tumors adjacent to a branch of the PA.

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  • Radiofrequency Ablation of Small Lung Metastases by a Single Application of a 2-cm Expandable Electrode: Determination of Favorable Responders Reviewed

    Jun Sakurai, Takao Hiraki, Hidefumi Mimura, Hideo Gobara, Hiroyasu Fujiwara, Nobuhisa Tajiri, Yoshifumi Sano, Susumu Kanazawa

    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY   21 ( 2 )   231 - 236   2010.2

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    PURPOSE: To determine which lung metastases are most likely to be treated effectively with a single radiofrequency (RF) application (defined as two separate applications of RF energy at a single electrode position) with a multitined expandable electrode with arrays 2 cm in diameter.
    MATERIALS AND METHODS: The authors retrospectively evaluated 88 lung metastases (mean long-axis diameter, 0.9 cm) in 36 patients (20 men and 16 women; mean age, 57 years) treated with a single RF application with a multitined expandable electrode with arrays 2 cm in diameter. Based on follow-up computed tomographic examinations, the technique effectiveness rates were estimated with Kaplan-Meier analysis. Multiple variables were analyzed with the log-rank test to determine risk factors for local progression. Then, the technique effectiveness rates were again estimated when considering only metastases without risk factors and compared with those of other tumors.
    RESULTS: The median follow-up period was 13.2 months (range, 6.0-24.7 months). Tumor size greater than 1.0 cm (P = .033) and contact with the bronchus with an inner diameter of at least 2 mm (P = .047) were the significant risk factors for local progression. The technique effectiveness rates for metastases 1.0 cm or smaller that were not in contact with the bronchus (n = 59) were 96% at 1 year and at 2 years; those rates were significantly (P = .010) higher than those in other tumors (n = 29).
    CONCLUSIONS: A single RF application with a multitined expandable electrode with arrays 2 cm in diameter is most likely to suffice in small (&lt;= 1 cm) lung metastases not in contact with a bronchus.

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  • Intrapelvic Chronic Expanding Hematoma: Magnetic Resonance Imaging Findings with Pathological Correlation Reviewed

    Jun Sakurai, Shiro Akaki, Masaru Yonezawa, Ikuyo Horiguchi, Satoko Nakamura, Susumu Kanazawa

    MAGNETIC RESONANCE IN MEDICAL SCIENCES   9 ( 2 )   81 - 84   2010

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    Chronic expanding hematoma is rare and occasionally misdiagnosed as malignant neoplasm. We describe a case in the female pelvis and correlate findings from pathology and magnetic resonance imaging. On diffusion-weighted images (DWI), our patient's hematoma showed 2 different signal intensities, which corresponded to pathological features of fresh and altered blood components. DWI can distinguish between such pathological features of a chronic expanding hematoma.

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  • CT Fluoroscopy-Guided Biopsy of 1,000 Pulmonary Lesions Performed With 20-Gauge Coaxial Cutting Needles: Diagnostic Yield and Risk Factors for Diagnostic Failure Reviewed

    Takao Hiraki, Hidefumi Mimura, Hideo Gobara, Toshihiro Iguchi, Hiroyasu Fujiwara, Jun Sakurai, Yusuke Matsui, Daisaku Inoue, Shinichi Toyooka, Yoshifumi Sano, Susumu Kanazawa

    CHEST   136 ( 6 )   1612 - 1617   2009.12

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    Background: Although conventional CT scan-guided needle biopsy is an established diagnostic method for pulmonary lesions, few large studies have been conducted on the diagnostic outcomes of CT fluoroscopy-guided lung biopsy. We have conducted a retrospective analysis to evaluate the diagnostic outcomes of 1,000 CT fluoroscopy-guided lung biopsies performed with 20-gauge coaxial cutting needles.
    Methods: We determined the diagnostic yield of CT fluoroscopy-guided lung biopsies performed with 20-gauge coaxial cutting needles for 1,000 lesions in 901 patients. Independent risk factors for diagnostic failure (ie, nondiagnostic, false-positive, and false-negative results) were determined with multivariate logistic regression analysis.
    Results: The biopsy results were nondiagnostic in 0.6% of the lesions (6 of 1,000 lesions). The sensitivity and specificity for the diagnosis of malignancy was 94.2% (741 of 787 lesions) and 99.1% (211 of 213 lesions), respectively; diagnostic accuracy was 95.2% (952 of 1,000 lesions). For lesions measuring &lt;= 1.0 cm, the diagnostic accuracy was 92.7% (140 of 151 lesions). The significant independent risk factors for diagnostic failure were as follows: the acquisition of two or fewer specimens (odds ratio [OR], 2.43; p = 0.007), lesions in the lower lobe (OR, 2.50; p = 0.003), malignant lesions (OR, 7.16; p = 0.007), and lesions measuring &lt;= 1.0 cm (OR, 3.85; p = 0.016) and &gt;= 3.1 cm (OR, 4.32; p = 0.007).
    Conclusions: CT fluoroscopy-guided lung biopsy performed with 20-gauge coaxial cutting needles resulted in a high diagnostic yield, even in the case of small lesions. Factors such as the acquisition of two or fewer specimens, lesions in the lower lobe, malignant lesions, and lesions measuring &lt;= 1.0 cm or &gt;= 3.1 cm significantly increased the rate of diagnostic failure. (CHEST 2009; 136:1612-1617)

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  • Pulmonary Edema as a Complication of Transcatheter Embolization of Renal Angiomyolipoma in a Patient with Pulmonary Lymphangioleiomyomatosis Due to Tuberous Sclerosis Complex Reviewed

    Takao Hiraki, Hidefumi Mimura, Hideo Gobara, Hiroyasu Fujiwara, Toshihiro Iguchi, Jun Sakurai, Seiichiro Norikane, Katsuya Kato, Susumu Kanazawa

    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY   20 ( 6 )   819 - 823   2009.6

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    Tuberous sclerosis complex (TSC) is an autosomal-dominant disorder characterized by seizures, mental retardation, and various hamartomatous lesions including renal angiomyolipoma (AML) and pulmonary lymphangioleiomyomatosis. A 22-year-old woman with TSC presented with multiple renal AMLs exceeding 4 cm in diameter. She underwent two transcatheter embolization procedures with a mixture of ethanol and iodized oil. She complained of dyspnea and minor hemoptysis 4 and 6 hours after the procedure. Findings on chest radiographs and computed tomographic images were indicative of pulmonary edema. The patient was treated with conservative therapy. The possible causes of the pulmonary edema are discussed in the text.

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  • Infusion of Hypertonic Saline into the Lung Parenchyma during Radiofrequency Ablation of the Lungs with Multitined Expandable Electrodes: Results Using a Porcine Model Reviewed

    Tatsuhiko Iishi, Takao Hiraki, Hidefumi Mimura, Hideo Gobara, Taichi Kurose, Hiroyasu Fujiwara, Jun Sakurai, Hiroyuki Yanai, Tadashi Yoshino, Susumu Kanazawa

    ACTA MEDICA OKAYAMA   63 ( 3 )   137 - 144   2009.6

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    The present study was performed to clarify the effect of hypertonic saline infusion into the lung parenchyma on radiofrequency ablation (RFA) of the lungs. A total of 20 ablation zones were created in 3 pigs. The ablation zones were divided into 3 groups. Group 1 (n = 6) consisted of ablation zones created by applying smaller radiofrequency (RF) power without saline infusion; group 2 (n = 5) zones were created by applying greater RF power without saline infusion; and group 3 (n = 9) zones were created by applying greater RF power with saline infusion. The techniques of saline infusion included administration of hypertonic saline 1 ml before RFA, followed by continuous administration at a rate of 1 ml/min during the first 2 min after the initiation of RFA. The ablation parameters and coagulation necrosis volumes were compared among the groups. Group 3 had a tendency toward smaller mean impedance than group 1 (p = 0.059) and group 2 (p = 0.053). Group 3 showed significantly longer RF application time than group 2 (p = 0.004) and significantly greater maximum RF power than group 1 (p = 0.001) and group 2 (p = 0.004). Group 3 showed significantly larger coagulation necrosis volume (mean, 1,421 mm(3)) than group 2 (mean, 858 mm(3), p = 0.039) and had a tendency toward larger necrosis volume than group 1 (mean, 878 mm(3), p = 0.077). Although this small study had limited statistical power, hypertonic saline infusion during RFA appeared to enlarge coagulation necrosis of the lung parenchyma.

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  • Percutaneous Coil Embolization Using the Direct Puncture Technique for a Subclavian Artery Pseudoaneurysm After Inadvertent Puncture Reviewed

    Hidefumi Mimura, Hideo Gobara, Takao Hiraki, Hiroyasu Fujiwara, Jun Sakurai, Kenji Sugiu, Susumu Kanazawa

    CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY   32 ( 2 )   371 - 373   2009.3

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  • Two Cases of Needle-Tract Seeding after Percutaneous Radiofrequency Ablation for Lung Cancer Reviewed

    Takao Hiraki, Hidefumi Mimura, Hideo Gobara, Yoshifumi Sano, Hiroyasu Fujiwara, Toshihiro Iguchi, Jun Sakurai, Ryotaro Kishi, Susumu Kanazawa

    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY   20 ( 3 )   415 - 418   2009.3

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    The authors describe two cases of needle-tract seeding after percutaneous radiofrequency (RF) ablation for lung cancer. Needle biopsy was performed immediately before RF ablation in one case. In both cases, RF ablation was performed with a single internally cooled electrode, which was removed without cauterizing the electrode tract. The seeding nodule appeared 4 or 7 months after RF ablation and was then completely treated with a repeat RF ablation.

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  • Measurement of pleural temperature during radiofrequency ablation of lung tumors to investigate its relationship to occurrence of pneumothorax or pleural effusion Reviewed

    Nobuhisa Tajiri, Takao Hiraki, Hidefumi Mimura, Hideo Gobara, Takashi Mukai, Soichiro Hase, Hiroyasu Fujiwara, Toshihiro Iguchi, Jun Sakurai, Motoi Aoe, Yoshifumi Sano, Hiroshi Date, Susumu Kanazawa

    CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY   31 ( 3 )   581 - 586   2008.5

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    The purpose of this study was to investigate the relationship between pleural temperature and pneumothorax or pleural effusion after radiofrequency (RF) ablation of lung tumors. The pleural temperature was measured immediately outside the lung surface nearest to the tumor with a fiber-type thermocouple during 25 ablation procedures for 34 tumors in 22 patients. The procedures were divided into two groups depending on the highest pleural temperature: P-group I and P-group II, with highest pleural temperatures of &lt; 40 degrees C and &gt;= 40 degrees C, respectively. The incidence of pneumothorax or pleural effusion was compared between the groups. Multiple variables were compared between the groups to determine the factors that affect the pleural temperature. The overall incidence of pneumothorax and pleural effusion was 56% (14/25) and 20% (5/25), respectively. Temperature data in five ablation procedures were excluded from the analyses because these were affected by the pneumothorax. P-group I and P-group II comprised 10 procedures and 10 procedures, respectively. The incidence of pleural effusion was significantly higher in P-group II (4/10) than in P-group I (0/10) (p = 0.043). However, the incidence of pneumothorax did not differ significantly (p = 0.50) between P-group I (4/10) and P-group II (5/10). Factors significantly affecting the pleural temperature were distance between the electrode and the pleura (p &lt; 0.001) and length of the lung parenchyma between the electrode and the pleura (p &lt; 0.001). We conclude that higher pleural temperature appeared to be associated with the occurrence of pleural effusion and not with that of pneumothorax.

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  • CT-Guided placement of a drainage catheter within a pelvic abscess using a transsacral approach Reviewed

    Toshihiro Iguchi, Shinya Asami, Shinichiro Kubo, Hitoshi Kin, Kuniaki Katusi, Jun Sakurai, Takao Hiraki, Susumu Kanazawa

    CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY   30 ( 6 )   1277 - 1279   2007.11

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    A 66-year-old man underwent CT-guided drainage catheter placement within a pelvic abscess with a diameter of 46 mm. We performed the drainage by a transsacral approach because it was considered the safest and most feasible approach. An 8G bone marrow biopsy needle was used to penetrate the sacrum to create a path for subsequent drainage catheter insertion. After withdrawal of the biopsy needle, a 6 Fr catheter was advanced into the abscess cavity through the path using the Seldinger technique. Except for bearable pain, no procedure -related complications occurred. Twenty-nine days after the placement, the catheter was withdrawn safely and the abscess cavity had shrunk remarkably.

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  • Percutaneous radiofrequency ablation for clinical stage I non-small cell lung cancer: Results in 20 nonsurgical candidates Reviewed

    Takao Hiraki, Hideo Gobara, Tatsuhiko Iishi, Yoshifumi Sano, Toshihiro Iguchi, Hiroyasu Fujiwara, Nobuhisa Tajiri, Jun Sakurai, Hiroshi Date, Hidefumi Mimura, Susumu Kanazawa

    JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY   134 ( 5 )   1306 - 1312   2007.11

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    Objective: Our objective was to evaluate the outcomes of radiofrequency ablation for nonsurgical candidates with clinical stage I non-small cell lung cancer.
    Methods: This study was carried out on 20 nonsurgical candidates ( 11 men and 9 women; mean age, 75.6 years) with clinical stage I ( IA, n = 14; IB, n = 6) non-small cell lung cancer. All patients were deemed nonsurgical candidates because of poor pulmonary function ( n = 7), poor cardiac function ( n = 3), poor performance status ( n = 4), or refusal to undergo surgery ( n = 6). The mean long-axis tumor diameter was 2.4 cm. Twenty patients underwent 23 percutaneous ablation sessions, including 3 repeat sessions for the treatment of local progression. The outcomes of radiofrequency ablation were retrospectively evaluated.
    Results: Procedural complications included pneumothorax ( n = 13 [ 57%]) and pleural effusion ( n = 4 [ 17%]). One case of pneumothorax required chest tube placement. The median follow-up period was 21.8 months. Local progression was observed in 7 ( 35%) patients a median of 9.0 months after the first session. The local control rates were 72% at 1 year, 63% at 2 years, and 63% at 3 years. The mean survival time was 42 months. The overall survivals and cancer-specific survivals were 90% and 100% at 1 year, 84% and 93% at 2 years, and 74% and 83% at 3 years, respectively.
    Conclusions: Treating clinical stage I non-small cell lung cancer with one or more radiofrequency ablation sessions provided promising outcomes in terms of survival, although the rate of local progression was relatively high. A prospective study with a larger population and longer follow-up is warranted.

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  • Percutaneous radiofrequency ablation for pulmonary metastases from colorectal cancer: Midterm results in 27 patients Reviewed

    Takao Hiraki, Hideo Gobara, Tatsuhiko Iishi, Yoshifumi Sano, Toshihiro Iguchi, Hiroyasu Fujiwara, Nobuhisa Tajiri, Jun Sakurai, Hiroshi Date, Hidefumi Mimura, Susumu Kanazawa

    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY   18 ( 10 )   1264 - 1269   2007.10

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    PURPOSE: To retrospectively evaluate the midterm outcomes (eg, safety, local efficacy, and survival) after radiofrequency (RF) ablation for pulmonary metastases from colorectal cancer.
    MATERIALS AND METHODS: Twenty-seven patients (19 men and eight women; mean age, 61.6 years) with 49 pulmonary metastases (mean long axis diameter, 1.5 cm) from colorectal cancer underwent 41 percutaneous computed tomography (CT)-guided RF ablation sessions. Follow-up examinations were performed with CT by using contrast medium administration in all patients; positron emission tomography was performed in five patients. The safety of the procedure, local tumor control, and patient survival were evaluated. Multiple variables were analyzed to determine prognostic factors.
    RESULTS: Pneumothorax occurred after 20 of the 41 sessions (49%), three of which necessitated chest tube placement. A small pleural effusion was found after six of the 41 sessions (15%). No maj or hemorrhagic event was observed. None of the patients died due to the procedure. The median follow-up period was 20.1 months (range, 11.2-47.7 months). The primary and secondary technique effectiveness rates were 72% and 85%, respectively, at 1 year, 56% and 62% at 2 years, and 56% and 62% at 3 years. The overall survival rates after RF ablation were 96% at 1 year, 54% at 2 years, and 48% at 3 years. The presence of extrapulmortary metastasis was determined to be a prognostic factor (P =.001).
    CONCLUSIONS: The midterm outcomes of percutaneous RF ablation for colorectal pulmonary metastases appear promising. The presence of extrapulmonary metastasis had an adverse effect on survival after RF ablation.

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  • Nonfatal systemic air embolism complicating percutaneous CT-guided transthoracic needle biopsy - Four cases from a single institution Reviewed

    Takao Hiraki, Hiroyasu Fujiwara, Jun Sakurai, Toshihiro Iguchi, Hideo Gobara, Nobuhisa Tajirl, Hidefumi Mimura, Susumu Kanazawa

    CHEST   132 ( 2 )   684 - 690   2007.8

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    Background: Systemic air embolism is recognized as a potentially fatal but extremely rare complication following percutaneous transthoracic needle biopsy. However, its incidence might be underestimated by missing systemic air in patients without cardiac or cerebral symptoms. Methods: This study was based on four cases (one man and three women; age range, 54 to 75 years) of systemic air embolism complicating CT scan-guided transthoracic needle biopsy, which were encountered among 1,010 procedures performed at our institution from April 1999 to December 2006. The target lesion was a lung tumor in three patients, and a mediastinal tumor in one patient. The procedure was performed percutaneously under CT scan-fluoroscopic guidance by using a coaxial biopsy needle system. Results: In all four patients, a specimen was successfully obtained from the lesions. During or immediately after the procedure, all patients experienced paroxysms of coughing. In three patients without cardiac or cerebral symptoms, the presence of systemic air was confirmed on postprocedural CT scan images; it was resolved without causing morbidity after the immediate therapy. The presence of systemic air was missed in one initially asymptomatic patient, resulting in a subsequent neurologic deficit. Conclusions: Systemic air embolism following CT scan-guided. transthoracic needle biopsy was encountered more frequently than would be expected. The considerable attention we gave to this complication enabled us to recognize it in patients without cardiac or cerebral symptoms. No sequelae were observed in the three patients in whom systemic air embolism was detected, and the therapy was initiated immediately, whereas missing systemic air led to cerebral embolism in one patient in our four cases.

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  • Transhepatic approach for percutaneous computed-tomography-guided radiofrequency ablation of renal cell carcinoma Reviewed

    Toshihiro Iguchi, Takao Hiraki, Hideo Gobara, Takashi Mukai, Soichiro Hase, Hiroyasu Fujiwara, Nobuhisa Tajiri, Jun Sakurai, Hidefumi Mimura, Takashi Saika, Hiromi Kumon, Susumu Kanazawa

    CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY   30 ( 4 )   765 - 769   2007.7

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    We performed percutaneously radiofrequency (RF) ablation of 5 renal cell carcinomas (mean diameter 26 +/- 15 mm) with computed-tomography (CT) fluoroscopic guidance using the transhepatic route. The RF electrode was successfully advanced into all tumors. RF ablation caused one minor complication (small asymptomatic perirenal hematoma); no major complications occurred. The follow-up contrast-enhanced CT images showed no local tumor progression of any tumors in a median period of 10 months (range 3-14 months). In conclusion, it seems that this transhepatic approach is safe and can be an alternative method for electrode insertion during RF ablation of selected renal tumors.

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  • Percutaneous radiofrequency ablation of lung tumors close to the heart or aorta: Evaluation of safety and effectiveness Reviewed

    Toshihiro Iguchi, Takao Hiraki, Hideo Gobara, Hidefumi Mimura, Hiroyasu Fujiwara, Nobuhisa Tajiri, Jun Sakurai, Kotaro Yasui, Hiroshi Date, Susumu Kanazawa

    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY   18 ( 6 )   733 - 740   2007.6

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    PURPOSE: The authors retrospectively evaluated the safety and effectiveness of percutaneous radiofrequency ablation of lung tumors close to the heart or aorta.
    MATERIALS AND METHODS: Forty-two tumors (mean diameter, 25 mm +/- 16; range, 5-73 mm) located less than 10 mm. from the heart or aorta were treated with radiofrequency ablation in 47 sessions. Lung tumors were classified into two groups according to their distance from the heart or aorta: group A (n = 27) comprised tumors at a distance of 1-9 mm; group B (n = 15) comprised contiguous tumors (distance, 0 mm). The safety and technique effectiveness of the procedure, defined as no evidence of local tumor progression, were evaluated.
    RESULTS: Radiofrequency ablation was feasible for all the 42 tumors. Procedural complications included asymptomatic pleural effusion (n = 5), small pneumothorax (n = 11), pneumothorax that necessitated chest tube placement (n = 4), and lung abscess (n = 1). No complications related to the specific tumor location, such as the accidental insertion of the electrode into the heart or aorta, pericardial effusion, arrhythmia, or cardiac infarction, occurred. The overall primary technique effectiveness rate was 75.8%, 45.9%, and 45.9% at 6, 12, and 24 months, respectively. This rate in group A (94.7%, 69.3%, and 69.3% at 6, 12, and 24 months, respectively) was significantly (P &lt; .001) higher than that in group B (42.9% and 8.6% at 6 and 12 months, respectively).
    CONCLUSIONS: Radiofrequency ablation of lung tumors close to the heart or aorta was safely performed. The local control of tumors contiguous to the heart or aorta was considerably lower compared with the tumors that were close but not contiguous to these structures.

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  • Radiofrequency ablation followed by radiation therapy for large primary lung tumors Reviewed

    Takashi Mukai, Hidefumi Mimura, Hideo Gobara, Mitsuhiro Takemoto, Kengo Himei, Takao Hiraki, Soichiro Hase, Hiroyasu Fujiwara, Toshihiro Iguchi, Nobuhisa Tajiri, Jun Sakurai, Kotaro Yasui, Yoshifumi Sano, Hiroshi Date, Susumu Kanazawa

    ACTA MEDICA OKAYAMA   61 ( 3 )   177 - 180   2007.6

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    We report the clinical experience of radiofrequency ablation followed by radiation therapy for large primary lung tumors. Two patients with large primary lung tumors were treated with combined radiofrequency ablation and radiation therapy, and good local control was observed. Combined radiofrequency ablation and radiation therapy that involves minimally invasive techniques appears to be promising for the treatment of large lung tumors.

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  • Intractable pneumothorax due to bronchopleural fistula after radiofrequency ablation of lung tumors Reviewed

    Jun Sakurai, Takao Hiraki, Takashi Mukai, Hidefumi Mimura, Kotaro Yasui, Hideo Gobara, Soichiro Hase, Hiroyasu Fujiwara, Toshihiro Iguchi, Nobuhisa Tajiri, Motoi Aoe, Yoshifumi Sano, Hiroshi Date, Susumu Kanazawa

    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY   18 ( 1 )   141 - 145   2007.1

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    We describe two cases of intractable pneumothorax that were attributed to a bronchopleural fistula (BPF) after radiofrequency ablation of lung tumors. In both cases, radiofrequency ablation induced necrosis of the lung tissue between the pleural space and the bronchus. The bronchopleural fistula formed after sloughing of the necrotic tissue. Management of the bronchopleural fistula was quite challenging, requiring frequent treatments, including pleurodesis, endobronchial management, and/or surgical repair. In one of the patients, air leakage persisted despite these efforts, and the patient died of acute pneumonia 52 days after the procedure. Although it is rare, with an incidence of 0.6% (2/334) at our institution, intractable pneumothorax due to bronchopleural fistula should be recognized as a risk associated with radiofrequency ablation of lung tumors.

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  • Risk factors for local progression after percutaneous radiofrequency ablation of lung tumors - Evaluation based on a preliminary review of 342 tumors Reviewed

    Takao Hiraki, Jun Sakurai, Toshihide Tsuda, Hideo Gobara, Yoshifumi Sano, Takashi Mukai, Soichiro Hase, Toshihiro Iguchi, Hiroyasu Fujiwara, Hiroshi Date, Susumu Kanazawa

    CANCER   107 ( 12 )   2873 - 2880   2006.12

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    Language:English   Publishing type:Research paper (scientific journal)   Publisher:JOHN WILEY & SONS INC  

    BACKGROUND. The purpose of the study was to retrospectively evaluate the risk factors for local progression after percutaneous radiofrequency (AF) ablation of lung tumors.
    METHODS. The study included 128 patients (77 men, 51 women; mean age, 61.3 years) with 342 tumors (25 primary and 317 metastatic lung neoplasms; mean long-axis diameter, 1.7 cm) treated with RF ablation. The overall primary, and secondary technique effectiveness rates were estimated using Kaplan-Meier analysis. Multiple variables were analyzed using the log-rank test, followed by multivariate multilevel analysis to determine independent risk factors for local progression. The primary and secondary technique effectiveness rates were again estimated when considering only tumors without independent risk factors.
    RESULTS. The median follow-up period was 12 months (range, 6-47 months). The overall primary and secondary technique effectiveness rates were 72% and 84% at 1 year, 60% and 71% at 2 years, and 58% and 66% at 3 years, respectively. Larger turner size (hazard ratio [HR], 1.97; 95% confidence interval [95% CI], 1.47-2.65; P &lt;.00001) and the use of an internally cooled electrode (HR, 2.32; 95% CI, 1.10-4.90; P=.027) were assessed as independent risk factors for local progression. The primary and secondary technique effectiveness rates when considering tumors smaller than 2 cm and treated with a multitined expandable electrode were 89% and 89% at 1 year and 66% and 78% at 2 years, respectively.
    CONCLUSIONS. Larger tumor size and the use of an internally cooled electrode were independent risk factors for local progression after RF ablation of lung tumors.

    DOI: 10.1002/cncr.22333

    Web of Science

    PubMed

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  • Radiofrequency ablation of normal lungs after pulmonary artery embolization with use of degradable starch microspheres: Results in a porcine model Reviewed

    Takao Hiraki, Hideo Gobara, Jun Sakurai, Hidefumi Mimura, Takashi Mukai, Soichiro Hase, Toshihiro Iguchi, Hiroyasu Fujiwara, Nobuhisa Tajiri, Hiroyuki Yanai, Tadashi Yoshino, Susumu Kanazawa

    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY   17 ( 12 )   1991 - 1998   2006.12

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    Language:English   Publishing type:Research paper (scientific journal)   Publisher:LIPPINCOTT WILLIAMS & WILKINS  

    PURPOSE: The present study was performed to evaluate the effect of pulmonary artery embolization on radiofrequency (RF) ablation of normal porcine lungs.
    MATERIALS AND METHODS: RF ablation zones (n = 34) were created in the normal lungs of five domestic pigs (five zones in each of the first two pigs and eight zones in each of the remaining three pigs) with an expandable multitined electrode with use of bilateral thoracotomy. RF ablation was performed without pulmonary artery embolization (group 1, n = 8), immediately after embolization (group 2, n = 11),15 minutes after embolization (group 3, n = 7), and 30 minutes after embolization (group 4, n = 8) with degradable starch microspheres. Among them, 12 ablation zones were excluded from this study because they were considerably limited by the presence of the pleura or large bronchi. The remaining 22 zones were included (n = 7, n = 5, n = 4, and n = 6 in groups 1, 2, 3, and 4, respectively). Coagulation necrosis volumes in the ablation zones were measured and compared among the groups.
    RESULTS: Coagulation necrosis volumes were 0.9 +/- 0.5 cm(3), 2.1 +/- 0.4 cm(3), 2.1 +/- 1.0 cm(3), and 1.9 +/- 0.6 cm(3) in groups 1, 2, 3, and 4, respectively. Groups 2-4 showed significantly larger coagulation volumes than group 1 (P = .012, P = .023, and P = .010 in groups 2, 3, and 4, respectively).
    CONCLUSION: Pulmonary artery embolization contributed to larger volumes of coagulation necrosis after RF ablation of normal lungs.

    DOI: 10.1097/01.RVI.0000251152.12254.AC

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  • Sloughing of intraductal tumor thrombus of hepatocellular carcinoma after transcatheter chemoembolization causing obstructive jaundice and acute pancreatitis Reviewed

    T Hiraki, J Sakurai, H Gobara, H Kawamoto, T Mukai, S Hase, Hiroyasu, NI Tajiri, Y Shiratori, S Kanazawa

    JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY   17 ( 3 )   583 - 585   2006.3

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    Language:English   Publisher:LIPPINCOTT WILLIAMS & WILKINS  

    DOI: 10.1097/01.RVI.0000200055.74822.ED

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Books

  • 絶対失敗しない!臨床研究実践ナビ : 臨床研究法時代のトラブル防止法を教えます

    菅原, 岳史( Role: Joint editor)

    メディカル・サイエンス・インターナショナル  2020.5  ( ISBN:9784815701956

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    Total pages:viii, 214p   Language:Japanese

    CiNii Books

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  • 絶対に知るべき臨床研究の進め方 : PMDAで得た研究者の心構え48

    レギュラトリー・ドクターズ

    メジカルビュー社  2016  ( ISBN:9784758316248

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    Language:Japanese

    CiNii Books

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MISC

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Presentations

  • がん研究におけるHybrid研究者 Invited

    櫻井 淳

    第80回日本癌学会学術総会  2021.10.2  日本癌学会

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    Event date: 2021.9.29 - 2021.10.2

    Language:Japanese   Presentation type:Symposium, workshop panel (nominated)  

    Venue:横浜  

  • Sustainable Development of 若手統計家 Invited

    櫻井 淳

    ARO協議会第8回学術集会  2021.9.10 

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    Event date: 2021.9.10 - 2021.9.11

    Language:Japanese   Presentation type:Symposium, workshop panel (nominated)  

  • 岡山大学における産学共創イノベーション創出の取組 Invited

    櫻井 淳

    RA協議会第7回年次大会  2021.9.14 

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    Event date: 2021.9

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

  • 臨床研究法は医療機器開発を加速できるのか Invited

    櫻井 淳

    第4回実践に基づく医療イノベーション研究会  2021.6.6  実践に基づく医療イノベーション研究会

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    Event date: 2021.6.4 - 2021.6.6

    Language:Japanese   Presentation type:Symposium, workshop panel (nominated)  

  • 新規デバイスの開発と承認-具体的な事案、今後の展望を交えて Invited

    櫻井 淳

    第50回日本IVR学会総会  2021.5.20  日本IVR学会

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    Event date: 2021.5.20 - 2021.5.22

    Language:English   Presentation type:Symposium, workshop panel (nominated)  

    Venue:神戸  

  • 岡山大学病院における産学共創イノベーション創出の取組 Invited

    櫻井淳

    岡山大学スタートアップ・新規事業創出強化セミナー  2021.3.30  岡山大学

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    Event date: 2021.3.30

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 岡山大学病院におけるバイオデザインセミナー Invited

    櫻井淳

    第1回日本バイオデザイン学会 定期学術集会  2021.3.5  日本バイオデザイン学会

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    Event date: 2021.3.5

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • 病院でものづくり~病院滞在型人材教育と医療ニーズ探索・研究開発のご案内~

    櫻井淳

    KMSメディカル・アーク2021 with MTO  2021.2.10  川崎医科大学

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    Event date: 2021.2.10

    Language:Japanese   Presentation type:Poster presentation  

    Country:Japan  

  • 特定臨床研究の実施体制・審査体制 Invited

    櫻井淳

    2020年度 治験・倫理委員会委員研修  2021.1.16  岡山大学病院

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    Event date: 2021.1.16

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 次世代医療機器連携拠点の紹介(岡山大学) Invited

    櫻井淳

    2020年度MDF第6回医工連携マッチング例会  2020.12.21  大阪商工会議所

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    Event date: 2020.12.21

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 医療系における産学連携の実際 Invited

    櫻井淳

    医療機器開発特別セミナー  2020.12.9  神戸大学医学部附属病院

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    Event date: 2020.12.9

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 臨床研究におけるプロジェクトマネジメントの本質と適用 Invited

    櫻井淳

    令和2年度 上級者臨床研究コーディネーター養成研修  2020.11.15  岡山大学病院

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    Event date: 2020.11.14 - 2020.11.15

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 医薬品開発のプロジェクトマネジメント Invited

    櫻井淳

    PharmaTrain教育/PRPコース2  2020.10.17  大阪大学大学院薬学研究科

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    Event date: 2020.10.17

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 医薬品開発のプロジェクトマネジメント Invited

    櫻井淳

    PharmaTrain教育/PRPコース1  2020.10.10  大阪大学大学院薬学研究科

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    Event date: 2020.10.10

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 次世代医療機器連携拠点整備等事業における岡山大学の取組み Invited

    櫻井淳

    医療機器開発連携推進ネットワーク「和」8拠点合同シンポジウム  2020.9.18  北海道大学

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    Event date: 2020.9.18 - 2020.9.19

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • ロボット穿刺技術の開発と薬事承認 Invited

    櫻井淳

    第49回日本IVR学会総会  2020.8.25  日本IVR学会

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    Event date: 2020.8.25 - 2020.8.27

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • アカデミア発 医療機器開発の現状と課題 Invited

    櫻井淳

    ARO協議会第7回学術集会  2019.9  一般社団法人ARO協議会

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    Event date: 2019.9

    Language:Japanese   Presentation type:Poster presentation  

    Country:Japan  

  • Investigator-initiated Clinical Trial for Medical Devices and Regulatory Points to Consider Invited International conference

    Sakurai Jun

    2019.7.1 

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    Event date: 2019.7.1

    Language:English   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • 創薬系シーズの実用化に向けて Invited

    櫻井淳

    ジャパン・ヘルスケアアドベンチャー・サミット2018  2018.10 

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    Event date: 2018.10

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • クラウド型研究支援管理システムを活用したARO業務効率化 Invited

    櫻井淳

    ARO協議会第6回学術集会  2018.9  一般社団法人ARO協議会

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    Event date: 2018.9

    Language:Japanese   Presentation type:Poster presentation  

    Country:Japan  

  • オープンイノベーション時代におけるAROの役割と展望 Invited

    櫻井淳

    第2回実践に基づく医療イノベーション研究会  2018.6 

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    Event date: 2018.6

    Language:Japanese   Presentation type:Symposium, workshop panel (nominated)  

    Country:Japan  

  • 臨床研究中核病院としての岡山大学病院の取り組みについて Invited

    櫻井淳

    岡山大学知恵の見本市2017  2017.12 

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    Event date: 2017.12

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • 岡山大学病院における臨床研究モニタリングとQMS体制整備 Invited

    櫻井 淳

    平成28年度中国地区臨床研究・治験活性化連絡協議会  2017 

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    Event date: 2017

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • アカデミアにおける医師主導治験のプロジェクトマネジメント Invited

    櫻井 淳

    第3回JSGCT臨床試験トレーニングコース2017  2017 

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    Event date: 2017

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 「若者よ来たれ!次世代を担うのは自分たちだ(シンポジウム)」 Invited

    櫻井 淳

    第1回レギュラトリーサイエンスのあり方研究会  2017 

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    Event date: 2017

    Language:Japanese   Presentation type:Symposium, workshop panel (nominated)  

    Country:Japan  

  • 臨床研究の現状と未来像 Invited

    櫻井 淳

    第7回メディカルアフェアーズ研究会  2017 

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    Event date: 2017

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • 国産医療機器創出促進基盤整備等事業 Invited

    櫻井 淳

    中央西日本メディカルイノベーション2017  2017 

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    Event date: 2017

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • 医療機器治験の特徴と実際 Invited

    櫻井 淳

    第19回CRC養成フォローアップ研修会  2017 

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    Event date: 2017

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • 医師主導治験におけるプロジェクトマネジメントの実際 Invited

    櫻井 淳

    平成28年度九州大学臨床研究セミナー  2017 

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    Event date: 2017

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • 医療機器治験の特徴と実際 Invited

    櫻井 淳

    第18回CRC養成フォローアップ研修会  2016 

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    Event date: 2016

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 医療機器治験の特徴と実際 Invited

    櫻井 淳

    平成28年度広島県臨床研究・CRC研修会  2016 

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    Event date: 2016

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • PMDA講座 Invited

    櫻井 淳

    平成27年度次世代医療機器開発プロフェッショナル育成プログラム育成アドバンストコース  2015 

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    Event date: 2015

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • Point to consider in evaluation of bio-absorbable stent Invited International conference

    Sakurai Jun

    2015 

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    Event date: 2015

    Language:English   Presentation type:Oral presentation (invited, special)  

    Country:United States  

  • 医療機器の使用成績評価 Invited

    櫻井 淳

    神戸大学国産医療機器創出促進基盤整備等事業  2015 

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    Event date: 2015

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • アカデミアが目指す臨床開発 Invited

    櫻井 淳

    第36回岡山歯学会  2015 

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    Event date: 2015

    Language:Japanese   Presentation type:Oral presentation (keynote)  

    Country:Japan  

  • 医療機器の使用成績評価 Invited

    櫻井 淳

    第20回グローバルメディカルベンチャーサロン  2015 

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    Event date: 2015

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • AROとCROの戦略的連携について Invited

    櫻井 淳

    エイツーヘルスケア株式会社社内研修  2015 

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    Event date: 2015

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • 臨床試験のモニタリング Invited

    櫻井 淳

    臨床研究デザインワークショップ  2015 

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    Event date: 2015

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • PMDAにおける医療機器審査について Invited

    櫻井 淳

    第104回医用工学研究会  2015 

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    Event date: 2015

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • The point at issue of the PMDA review for Embosphere and HepaSphere Microspheres

    Sakurai Jun

    2014 

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    Event date: 2014

    Language:English   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 医療機器審査と治験・臨床研究 Invited

    櫻井 淳

    第63回岡山血管造影・Interventional Radiology研究会  2014 

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    Event date: 2014

    Language:Japanese   Presentation type:Oral presentation (keynote)  

    Country:Japan  

  • 医療機器の審査・承認 Invited

    櫻井 淳

    第45回全国国立大学法人放射線診療部門会議  2014  全国国立大学法人放射線診療部門会議

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    Event date: 2014

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • Clinical Trial for Medical Device Invited

    櫻井 淳

    PMDA Training seminar  2014 

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    Event date: 2014

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Country:Japan  

  • ディーシービーズにおける医療機器審査の概要と論点

    櫻井 淳

    第49回日本医学放射線学会秋季臨床大会  2013  一般社団法人日本医学放射線学会

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    Event date: 2013

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  •  十二指腸静脈瘤に対してIVRを施行した3例 Invited

    櫻井 淳

    第5回 瀬戸内肝胆膵治療懇話会  2007 

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    Event date: 2007

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Country:Japan  

  • 健康寿命の延伸を目指す岡山大学の革新的医療技術研究開発体制

    櫻井淳

    令和元年革新的医療技術創出拠点プロジェクト成果報告会  2020.3 

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    Event date: 2020.3

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 健康寿命の延伸を目指す岡山大学の革新的医療技術研究開発体制

    櫻井淳

    平成29年度革新的医療技術創出拠点プロジェクト成果報告会  2018.3 

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    Event date: 2018.3

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 岡山大学の描く未来

    櫻井 淳

    革新的医療技術創出拠点プロジェクト平成28年度成果報告会  2017 

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    Event date: 2017

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • Efficacy and Safety of Transjugular Liver Biopsy for the Patients with Massive Ascites or Severe Coagulopathy Single Center Retrospective Study in Japan

    Sakurai Jun

    2016 

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    Event date: 2016

    Language:English   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 疾患レジストリ及びバイオバンク事業と連動した治験受託システムの構築

    櫻井 淳

    ARO協議会 第4回学術集会  2016  一般社団法人ARO協議会

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    Event date: 2016

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 医療機器治験の特徴と実際

    櫻井 淳

    第125回ネットワーク情報交換会  2016 

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    Event date: 2016

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • Triple coaxial法による動脈塞栓術を行ったType Ⅱ endoleakの2例

    櫻井 淳

    第26回 日本IVR学会中国四国地方会  2012 

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    Event date: 2012

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • Incidence and imaging findings of complications following endovascular aneurysm repair for abdominal aortic aneurysm International conference

    Sakurai Jun

    2012 

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    Event date: 2012

    Language:English   Presentation type:Poster presentation  

    Country:Japan  

  • 会陰部腫瘤の一例

    櫻井 淳

    第44回 岡山画像診断懇話会  2012 

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    Event date: 2012

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 神経線維腫症に合併した肋間動脈瘤破裂に対して血管塞栓術を行った1例

    櫻井 淳

    第39回 日本IVR学会総会  2010 

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    Event date: 2010

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 外傷性腸骨動脈仮性動脈瘤に対してePTFEステントグラフトを用いた血管形成術を行った1例

    櫻井 淳

    第23回 日本IVR学会中国・四国地方会  2009 

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    Event date: 2009

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • Management of pseudoaneurysms involving the main trunk or first branches of the celiac artery and superior mesenteric artery. International conference

    Sakurai Jun

    2008.4 

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    Event date: 2008.4

    Language:English   Presentation type:Poster presentation  

    Country:Japan  

  • 腹腔および上腸間膜動脈本幹・一次分枝に生じた仮性動脈瘤に対するIVR

    櫻井 淳

    第67回 日本医学放射線学会総会  2008  一般社団法人日本医学放射線学会

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    Event date: 2008

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 成人型腎芽腫の一例

    櫻井 淳

    第111回 日本医学放射線学会中国・四国地方会  2008  一般社団法人日本医学放射線学会

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    Event date: 2008

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 2cm展開針を用いた肺ラジオ波焼灼術:1部位焼灼における局所制御率および再発危険因子の検討

    櫻井 淳

    第66回 日本医学放射線学会学術集会  2007  一般社団法人日本医学放射線学会

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    Event date: 2007

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 肺ラジオ波焼灼療法後に肺仮性動脈瘤を認めた一例

    櫻井 淳

    第43回 日本医学放射線学会秋季臨床大会  2007  一般社団法人日本医学放射線学会

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    Event date: 2007

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 肺ラジオ波焼灼療法後に肺仮性動脈瘤を認めた一例

    櫻井 淳

    第21回 日本IVR学会中国・四国地方会  2007 

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    Event date: 2007

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 十二指腸静脈瘤に対してIVRが有効であった3例

    櫻井 淳

    第36回 日本IVR学会総会  2007 

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    Event date: 2007

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • Pneumothorax, pleural effusion, and chest tube placement after radiofrequency ablation of lung tumors: incidence and risk factors. International conference

    Sakurai Jun

    2006.11 

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    Event date: 2006.11

    Language:English   Presentation type:Oral presentation (general)  

    Country:United States  

  • 肺腫瘍に対する経皮的ラジオ波焼灼療法の中期治療成績

    櫻井 淳

    第65回 日本医学放射線学会学術集会  2006  一般社団法人日本医学放射線学会

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    Event date: 2006

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • PTO及びBRTOにて止血し得た十二指腸静脈瘤破裂の1例

    櫻井 淳

    第107回 日本医学放射線学会中国・四国地方会  2006  一般社団法人日本医学放射線学会

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    Event date: 2006

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • TAE後に胆管内腫瘍栓が脱落し閉塞性黄疸を来した肝細胞癌の1例

    櫻井 淳

    第105回 日本医学放射線学会中国・四国地方会  2005  一般社団法人日本医学放射線学会

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    Event date: 2005

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 強皮症を合併した子宮頸癌に対して根治的放射線治療を行った一例

    櫻井 淳

    第100回 日本医学放射線学会中国・四国地方会  2003  一般社団法人日本医学放射線学会

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    Event date: 2003

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 検診で発見された肺犬糸状虫症の1例

    櫻井 淳

    第101回 日本医学放射線学会中国・四国地方会  2003  一般社団法人日本医学放射線学会

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    Event date: 2003

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

  • 男性乳癌に対して乳房温存療法に施行した1例

    櫻井 淳

    第99回 日本医学放射線学会中国・四国地方会  2002  一般社団法人日本医学放射線学会

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    Event date: 2002

    Language:Japanese   Presentation type:Oral presentation (general)  

    Country:Japan  

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Research Projects

  • 新規光ファイバ焼灼医療機器の開発~経皮的針生検の合併症低減を目指して~

    Grant number:22K12865  2022.04 - 2025.03

    日本学術振興会  科学研究費助成事業 基盤研究(C)  基盤研究(C)

    馬越 紀行, 櫻井 淳, 深野 秀樹, 都地 友紘, 生口 俊浩

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    Grant amount:\4160000 ( Direct expense: \3200000 、 Indirect expense:\960000 )

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  • 光ファイバ治療器の動脈塞栓術への応用-新規医療機器開発ヘ向けて-

    Grant number:22K07772  2022.04 - 2025.03

    日本学術振興会  科学研究費助成事業 基盤研究(C)  基盤研究(C)

    生口 俊浩, 馬越 紀行, 櫻井 淳, 深野 秀樹, 都地 友紘

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    Grant amount:\4160000 ( Direct expense: \3200000 、 Indirect expense:\960000 )

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  • ロボットを用いた画像ガイド下骨穿刺の実現:自動穿刺アルゴリズムの構築

    Grant number:22H03028  2022.04 - 2025.03

    日本学術振興会  科学研究費助成事業 基盤研究(B)  基盤研究(B)

    平木 隆夫, 馬越 紀行, 櫻井 淳, 松宮 潔, 松野 隆幸, 松井 裕輔, 亀川 哲志, 松浦 龍太郎

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    Grant amount:\17030000 ( Direct expense: \13100000 、 Indirect expense:\3930000 )

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  • 温度センサが集積された広い適用性の極細レーザ照射光ファイバ加熱治療器の研究

    Grant number:22H03975  2022.04 - 2025.03

    日本学術振興会  科学研究費助成事業 基盤研究(B)  基盤研究(B)

    深野 秀樹, 馬越 紀行, 櫻井 淳, 生口 俊浩

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    Grant amount:\17680000 ( Direct expense: \13600000 、 Indirect expense:\4080000 )

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  • 国内医療機器産業の業界支援に関する研究

    Grant number:21IA2016  2021.04 - 2024.03

    厚生労働省  厚生労働行政推進調査事業費補助金 

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    Authorship:Principal investigator  Grant type:Competitive

    Grant amount:\4245000 ( Direct expense: \3266000 、 Indirect expense:\979000 )

  • Quality management of Advanced medical care clinical resarch under Clinical Trial Act for pharmaceutial approval application

    Grant number:20K12715  2020.04 - 2024.03

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

    櫻井 淳

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    Grant amount:\4290000 ( Direct expense: \3300000 、 Indirect expense:\990000 )

    この研究では、先進医療Bとして実施する臨床研究を薬事承認申請に活用するための試験の品質レベルを明らかにする。先進医療Bとして実施されてきた臨床研究(臨床研究法下の「特定臨床研究」に相当)は薬事承認申請の根拠となりうる。しかしながら特定臨床研究の成果を薬事承認申請の根拠資料として活用するための具体的な品質レベルについては未だ明確になされていない。またアカデミア発シーズ開発における試験コストの増加は開発を阻害するだけでなく、将来の保険医療化の際に、受益者(患者)負担の増加に繋がる。この研究により、特定臨床研究として実施する先進医療Bの品質レベルが明らかになれば、従来治験が行われていた開発初期の臨床試験(いわゆる探索的試験)を先進医療Bとして実施する可能性が高まり、試験の効率化、低コスト化が図られる。先進医療Bの位置づけが「仮説探索を行う試験」として明確になる。さらに医療現場での先進医療Bの増加に繋がる。
    2021年度は、臨床試験実施計画書の作成において、部門間の品質確保レベルが一定でないことに対するマネジメントとして、臨床試験実施計画書作成のフローと、リスクコミュニケーションを見直した。ツールとして、Data Process check、リスク特定/分析シート、試験コンセプトシート、品質マネジメントに関する計画書及び手順書、プロトコルレビューマニュアル、症例報告書ひな形の各文書をフォーマット化した。また統計解析責任者に対して先進医療Bを含む臨床試験全般の品質マネジメントの考え方を統計解析責任者の視点で解説してもらい、QMSの視点でスタッフの教育を行った。
    さらに、本研究を適応する先進医療B2試験と未承認医療機器特定臨床研究1件の支援を継続して行い、品質リスクマネジメントの実行性を確認した。

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  • CT透視下IVR用針穿刺ロボットにおける半自動穿刺システムの開発

    Grant number:19K08174  2019.04 - 2022.03

    日本学術振興会  科学研究費助成事業 基盤研究(C)  基盤研究(C)

    小牧 稔幸, 平木 隆夫, 亀川 哲志, 松野 隆幸, 金澤 右, 櫻井 淳, 松井 裕輔

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    Grant amount:\4290000 ( Direct expense: \3300000 、 Indirect expense:\990000 )

    我々はCTガイド下針穿刺ロボットを研究開発している。これまでの研究により,術者が本ロボットを遠隔操作することで精度良く標的に穿刺できることを,ファントム試験ならびに動物試験などの非臨床試験で実証している。2018年度にはFirst-in-human臨床試験を実施し、本ロボットは臨床での使用も可能であることを確認した。
    本ロボットはこれまで、術者が専用のコントローラを操作してロボットのすべての動きを遠隔操作するものであった。そこで本研究では,我々はロボットによる針穿刺を段階的に自動化することを目指した。まず,医師が用手で針穿刺を行う際にどのように軌道修正を行っているのかについてのデータ解析を行い、適切なフィードバックを実施するための指針を得た。また、ロボットを用いた穿刺手技のうち、針先を刺入点へと移動させるターゲティング行程、および狙った標的へ向け針を挿入する穿刺行程において、一部を自動化する半自動化穿刺システムを開発した。さらに,本ロボットにより針穿刺を行っている最中に発生する針のたわみを除去するためのロボット制御アルゴリズムを開発した。針のたわみはロボットアーム先端に取り付けた力センサーにより検出される。はりのたわみ量は片持ち梁としてモデル化され,たわみを最小化するロボットの位置姿勢を求める。これらの計算は、ロボット内部の計算機および操作インタフェースのソフトウェアとして実装されており,ロボットが計算に基づいて動作する。
    本研究で開発した以上のシステムの有効性や妥当性は、岡山大学病院のIVRセンターにおいてファントム実験を実施することで検証した。

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  • First-in-Human trial of CT fluoroscopy-guided biopsy using a remote controllable robot for needle insertion

    Grant number:18K07677  2018.04 - 2021.03

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

    Hiraki Takao

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    Grant amount:\4420000 ( Direct expense: \3400000 、 Indirect expense:\1020000 )

    The trial was performed in 2018. Ten patients (4 females and 6 males; mean age, 72 years) with lesions (mean maximum diameter, 28 mm) in the kidney, lung, mediastinum, adrenal, and muscle were enrolled. In all patients, robotic insertion of the introducer needle was feasible; pathological diagnosis was made. There was no machine-related trouble. A total of 11 adverse events occurred in 8 patients, including 10 grade I events and 1 grade IIIa event. Any event was not deemed to be related with the use of the robot. Effective dose to physicians during robotic needle insertion was zero in all cases. The results of the trial were presented in the annual meeting of Japanese Radiology Society and published in European Radiology.

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  • Robotically driven out-of-plane needle insertion

    Grant number:17K10439  2017.04 - 2020.03

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

    Sakurai Jun

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    Grant amount:\4550000 ( Direct expense: \3500000 、 Indirect expense:\1050000 )

    We developed a technique for robotic CT-guided out-of-plane needle insertion, and verified its accuracy. In the phantom experiment, we demonstrated that out-of-plane needle insertions performed using the robot were more accurate than manual insertions at the various angles. Furthermore, we succeeded in predicting the movement of the needle movement in vivo, and developed a method to correct the needle displacement in the tissue. In the animal experiment, robotic out-of-plane needle insertions were accurate in the in vivo procedure, particularly with adjustment during insertion.

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  • 国産医療機器創出促進基盤整備等事業

    Grant number:18hk0202002j00  2014.04 - 2019.03

    日本医療研究開発機構  国産医療機器創出促進基盤整備等事業 

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    Authorship:Principal investigator  Grant type:Competitive

    Grant amount:\38705000

  • 臓器の呼吸性移動を可視化する複合現実の開発:画像下低侵襲がん治療への実装に向けて

    Grant number:23K07083  2023.04 - 2026.03

    日本学術振興会  科学研究費助成事業  基盤研究(C)

    松井 裕輔, 諸岡 健一, 平木 隆夫, 櫻井 淳, 吉尾 浩太郎, 冨田 晃司

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    Grant amount:\4550000 ( Direct expense: \3500000 、 Indirect expense:\1050000 )

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  • 肺癌に対するマイクロ波焼灼術の安全性と有効性の検討ー単施設単群前向きオープン試験

    Grant number:22K07796  2022.04 - 2025.03

    日本学術振興会  科学研究費助成事業 基盤研究(C)  基盤研究(C)

    冨田 晃司, 宇賀 麻由, 櫻井 淳, 平木 隆夫, 松井 裕輔, 生口 俊浩

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    Grant amount:\4160000 ( Direct expense: \3200000 、 Indirect expense:\960000 )

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  • 岡山県出生前コホート構築研究

    Grant number:20K10498  2020.04 - 2023.03

    日本学術振興会  科学研究費助成事業  基盤研究(C)

    頼藤 貴志, 増山 寿, 櫻井 淳, 三橋 利晴, 小林 勝弘, 塚原 宏一

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    Grant amount:\4290000 ( Direct expense: \3300000 、 Indirect expense:\990000 )

    岡山県をベースに、妊娠中からAYA(思春期と若年成人)世代まで児の健康・成長・発達を追跡するための出生前コホートの立ち上げを目的とし、初年度に、本研究開始前よりパイロット的にデータ収集を行ってきた産科一次施設において、児の登録と出生前後に得られるデータの蓄積を行った。本年度も、データの蓄積を継続して行っている。一方、これまでに集積してきた、通常の診療において得られたデータ(妊婦の基本情報、入院時記録、妊娠中の経過、分娩記録など)及び入院期間中に同意をいただいた妊婦の方を対象に実施している紙ベースの質問票から得られたデータ(学歴、アレルギー歴、喫煙歴など)のデータベース化を図った。様々な仮説の検証において必要となる情報が網羅されたデータベースの基礎が構築できているものと考える。
    また、児追跡のため、満1歳以降毎年誕生月に送付を予定しているアンケートについては、データ収集の効率化を図るため、郵送方式からオンライン方式に計画を変更した。グーグルフォームを用いた「1歳時アンケート調査票」を作成し、岡山大学研究倫理審査委員会の承認を得ている。フォームの送付・回収方法、回収した情報のデータベースとの突合方法についても検討を重ね、産科一次施設の協力の下、追跡調査の手筈を整えることができており、産科一次施設での倫理審査の承認が得られ次第、調査実施開始の運びとなる。
    作成されたデータセットを用いて、仮説の検討を順次行い、論文化を目指す。

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Other research activities

  • Establishment of the core center for the promotion of open innovation and commercialization programs

    2019.08
    -
    2024.03

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    In this project, taking advantage of the scale merits of the mega-hospital consisting of five core hospitals in cooperation with Okayama University, we will pick up a wide range of medical needs, not only in medicine but also in nursing, nursing care, rehabilitation, dental fields, or home care. Business matching with industry and commercialization of medical needs should be achieved seamlessly, focusing on profitable business models. Draft documents according to the handling of medical needs, intellectual property, and commercialization at each cooperative hospital are established in this project.

 

Class subject in charge

  • Research Projects and Practicals: Regulatory Science (2023academic year) special  - その他

  • Lecture and Research Projects: Regulatory Science (2023academic year) special  - その他

  • Medical Ethics and Legal and Social Issues (2023academic year) special  - その他

  • Research Projects and Practicals: Regulatory Science (2022academic year) special  - その他

  • Lecture and Research Projects: Regulatory Science (2022academic year) special  - その他

  • Research Projects and Practicals:Regulatory Science (2020academic year) special  - その他

  • Lecture and Research Projects:Regulatory Science (2020academic year) special  - その他

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