Using AI and Fluorescence Guidance to Enhance Extrahepatic Bile Duct Identification Among Junior Surgeons During Laparoscopic Cholecystectomy

NCT ID: NCT07188181

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgical Education and Anatomical Identification in Laparoscopic Cholecystectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PGY Trainees

Postgraduate-year trainees with limited experience in laparoscopic cholecystectomy (\<20 cases).

No interventions assigned to this group

Junior Residents

Residents with moderate experience in laparoscopic cholecystectomy (20-50 cases)

No interventions assigned to this group

Senior Residents

Residents with advanced experience in laparoscopic cholecystectomy (\>50 cases).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Participants not available for the one-week washout and repeat assessment.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shih Min Yin

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

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Shih Min Yin

Kaohsiung City, Kaohsiung, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202301955B0

Identifier Type: -

Identifier Source: org_study_id

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