臨床研究等提出・公開システム

Date of registration	Jan. 07, 2026
Last modified on	Jan. 07, 2026
Trial ID	jRCT1032250626

Scientific Title	Development and implementation of an AI-driven intraoperative real-time biliary structure recognition system using ICG fluorescence imaging during laparoscopic cholecystectomy
Public Title	Creating an AI-based system to help doctors see bile ducts more clearly during surgery

Contact for Scientific Queries	Name	Saiura Akio
	Affiliation	Juntendo University Hospital
	Address	3-1-3 Hongo Bunkyoku Tokyo
	Telephone	+81-3-3813-3111
	E-mail	a-saiura@juntendo.ac.jp
Contact for Public Queries	Name	Kawano Fumihiro
	Affiliation	Juntendo University Hospital
	Address	3-1-3 Hongo Bunkyoku Tokyo
	Telephone	+81-3-3813-3111
	E-mail	fkawano@juntendo.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 07, 2026
Target sample size		300
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing laparoscopic cholecystectomy with ICG fluorescence imaging who meet all of the following criteria: 1.Aged 18 years or older at the time of consent. 2.Diagnosed with gallstones, cholecystitis, or gallbladder polyps. 3.Able to provide written informed consent based on sufficient explanation of the study, with full understanding and voluntary agreement by the participant.
	Exclusion Criteria	1.Patients who are unable or unwilling to provide informed consent. 2.Patients for whom indocyanine green cannot be administered at least two hours before surgery (e.g., emergency procedures). 3.Patients undergoing open surgery. 4.Pregnant 5.Minors or patients who have difficulty understanding the study in Japanese. 6.Any individual deemed unsuitable for participation by the principal investigator.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		gallstones, cholecystitis, or gallbladder polyps.
Health Condition(s) Keyword		gallstones, cholecystitis, or gallbladder polyps.
Primary Outcome(s)		The performance of the AI system will be evaluated using the macro-averaged F1 score. Methods: The F1 score will be calculated for each class, and their unweighted mean will be used as the macro-averaged F1 score. After the final model is fixed, evaluation will be performed once using the threshold determined from the development set. The 95% confidence interval will be estimated using patient-level bootstrapping (1,000 iterations).
Secondary Outcome(s)		Precision Recall ROC-AUC PR-AUC Balanced accuracy MCC Confusion matrix ICG visibility score Inter-rater agreement

Primary Sponsor	None

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Juntendo University Certified Review Board
Address	2-1-1Hongo, Bunkyo-ku, Tokyo, Tokyo
Telephone	+81-3-5802-1584
E-Mail	crbjun@juntendo.ac.jp
Approval Status	Approval
Date of approval	Nov. 07, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	the United States