- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06732271
LC-Smart: A Deep Learning-Based Quality Control Model for Laparoscopic Cholecystectomy
December 11, 2024 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Objective: Critical view of safety (CVS) is a successful technique to reduce bile duct injury during laparoscopic cholecystectomy (LC).
We aimed to create a deep learning-based quality control model for LC and reduce the learning curve for junior surgeons, which would automatically assess whether surgeons are CVS conscious during procedures.Methods: We retrospectively collected 308 LC videos from public datasets (Cholec80, Endoscapes) and Sun Yat-sen Memorial Hospital.
Video frames were labeled using binary classification and feature optimization methods, such as black border clipping and sliding windows.
Two neural networks, ResNet-50 and EfficientNetV2-S, were trained and evaluated based on F1 scores and accuracy.
Additionally, We created an online CVS recognition system (LC-Smart), tested it using 171 films from two hospitals, and compared the results to two local senior doctors.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
308
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510220
- Sun Yat-sen Memorial Hospital,Sun Yat-sen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
people with laparoscopic cholecystectomy
Description
Inclusion Criteria:
- complete video data with no missing footage;
- surgical procedure identified as laparoscopic cholecystectomy;
- full visibility of the surgical area in the video;
- successful completion of the procedure;
- absence of significant anatomical variations
- video resolution no less than 720×560.
Exclusion Criteria:
- substantial intraoperative adhesions
- a history of previous abdominal or pelvic procedures
- a conversion to open surgery during the procedure
- significant bleeding that obscured structural identification.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the surgical time
Time Frame: Nov/2023-Nov/2024
|
Nov/2023-Nov/2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2024
Primary Completion (Actual)
November 24, 2024
Study Completion (Actual)
November 30, 2024
Study Registration Dates
First Submitted
December 9, 2024
First Submitted That Met QC Criteria
December 11, 2024
First Posted (Estimated)
December 13, 2024
Study Record Updates
Last Update Posted (Estimated)
December 13, 2024
Last Update Submitted That Met QC Criteria
December 11, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- SYSKY-2024-1015-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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