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临床试验/NCT07188181
NCT07188181已完成不适用

AI and Fluorescence Help Junior Surgeons Identify the Bile Duct During Laparoscopic Cholecystectomy

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
CBD Recognition

研究概览

简要总结

The present study evaluates whether PGY trainees and surgical residents, with or without AI assistance, could accurately identify the presence and anatomical location of the CBD, as well as delineate intraoperative danger zones during LC.

详细描述

This retrospective cohort study evaluated the impact of artificial intelligence (AI) assistance on anatomical recognition during laparoscopic cholecystectomy (LC). Between June 2022 and December 2024, indocyanine green (ICG) fluorescence-guided LC videos were prospectively collected at a tertiary referral center. After excluding duplicate cases, 177 videos were used for model training, 15 for validation, and 15 for testing. Frames were extracted at 1 frame per second, and key structures including the common bile duct (CBD), cystic duct, cystic artery, liver, gallbladder, and surgical instruments were annotated by board-certified hepatobiliary surgeons to generate the ground truth dataset.

A YOLOv9 object detection model, incorporating Programmable Gradient Information (PGI) and Generalized Efficient Layer Aggregation Network (GELAN), was trained to recognize critical biliary anatomy. For the experimental phase, surgical trainees (postgraduate trainees, junior residents, and senior residents) reviewed condensed 2-3 minute surgical videos, segmented into 5-second clips. In the CBD recognition task, participants determined whether the CBD was visible in each clip. In the CBD annotation task, participants placed bounding boxes to indicate the CBD location on single frames, and additionally delineated a polygonal "dangerous zone" within Calot's triangle where further dissection is considered hazardous.

Each participant first performed both tasks without AI assistance. After a one-week washout, the same tasks were repeated with AI support, which displayed YOLOv9-generated bounding boxes to guide decision-making. The task order was randomized to minimize learning bias. Performance metrics included recognition accuracy, precision, recall, F1-score, and intersection over union (IoU).

This study was retrospectively registered after completion, as it used de-identified surgical videos and trainee assessments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Postgraduate-year (PGY) trainees with fewer than 20 laparoscopic cholecystectomy (LC) cases.
  • Junior residents with 20-50 LC cases.
  • Senior residents with more than 50 LC cases.

排除标准

  • Participants not available for the one-week washout and repeat assessment.

结局指标

主要结局

CBD Recognition

时间窗: During a single video review session (approximately 30-60 minutes per participant)

identify the presence of the CBD

次要结局

  • CBD annotation(During a single video review session (approximately 30-60 minutes per participant))

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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