掲載種別：研究論文（学術雑誌）   出版者・発行元：Oxford University Press (OUP)  

Abstract

Background

Robotic needle insertion under CT guidance has been developed, but data on comparison with manual insertion are still lacking.

Purpose

To compare robotic versus manual needle insertion for CT fluoroscopy-guided intervention, primarily in terms of insertion accuracy.

Materials and Methods

This was a prospective study between May 2020 and March 2023 at a single site. The cohort comprised 22 patients undergoing CT (Aquilion One or Aquilion CX; Canon Medical Systems) fluoroscopy-guided biopsy, who were randomly allocated to either the robotic or manual group. The robot used (Zerobot; Medicalnet Okayama) is not yet commercially available. A biopsy introducer needle was inserted by 1 of 3 physicians using a remote-control robot in the robotic group, versus by 1 of 3 different physicians by hand in the manual group. The primary endpoint was needle insertion accuracy, which was defined as the 3-dimensional Euclidean distance between a predetermined target point and the needle tip after insertion. The non-inferiority of robotic insertion to manual one was then tested. Adverse events were evaluated. Statistical comparisons were made between the 2 groups.

Results

Technical success and pathological findings were confirmed in all patients of the 2 groups. The mean and SD of needle insertion were 4.8 mm ± 2.6 in the robotic group and 7.0 mm ± 3.1 in the manual group (P < .001). The mean difference in accuracy between the 2 groups (robotic minus manual group) was −2.1 mm (95% CI, −4.7 to 0.4). Effective dose to physicians was zero in all cases in the robotic group, while median dose was 1.0 µSv in the manual group (P < .001). Dose length product to patients was not significantly different between the 2 groups (P = .100). No major adverse events were observed.

Conclusion

Robotic needle insertion was non-inferior to manual insertion in terms of accuracy, while it effectively eliminated radiation exposure to physicians.

Trial registration number

jRCT2062200013

DOI： 10.1093/radadv/umaf010

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その他リンク： https://academic.oup.com/radadv/article-pdf/2/2/umaf010/62871840/umaf010.pdf

記述言語：英語   掲載種別：研究論文（学術雑誌）  

Demonstrating drug efficacy in slowing kidney disease progression requires large clinical trials when targeting participants with an early stage of chronic kidney disease (CKD). In this randomized, parallel-group, open-labeled trial (CANPIONE study), we assessed the effect of the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin using the individual's change in estimated glomerular filtration rate (eGFR) slope before (pre-intervention slope) and during treatment (chronic slope).We randomly assigned (1:1) participants with type 2 diabetes, urinary albumin-to-creatinine ratio (UACR) of 50 to under 300 mg/g, and an eGFR of at least 45 ml/min/1.73m2 to receive canagliflozin or guideline-recommended treatment except for SGLT2inhibitors (control). The first and second primary outcomes were the geometric mean percentage change from baseline in UACR and the change in eGFR slope, respectively. Of 98 randomized participants, 96 received at least one study treatment. The least-squares mean change from baseline in log-transformed geometric mean UACR was significantly greater in the canagliflozin group than the control group (between group-difference, -30.8% (95% confidence interval -42.6 to -16.8). The between-group difference (canagliflozin group - control group) of change in eGFR slope (chronic - pre-intervention) was 4.4 (1.6 to 7.3) ml/min/1.73 m2 per year, which was more pronounced in participants with faster eGFR decline. In summary, canagliflozin reduced albuminuria and the participant-specific natural course of eGFR decline in participants with type 2 diabetes and microalbuminuria. Thus, the CANPIONE study suggest that the within-individual change in eGFR slope may be a novel approach to determine the kidney protective potential of new therapies in early stages of CKD.

DOI： 10.1016/j.kint.2024.08.019

PubMed

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開催年月日： 2024年3月7日

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開催年月日： 2021年9月10日 - 2021年9月11日

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記述言語：日本語  

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会議種別：ポスター発表  

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会議種別：ポスター発表  

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