Clinical Trial: Evaluation of the usefulness of an intraoperative focus point automatic identification model using deep learning in laparoscopic cholecystectomy (Japan)

Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058609) titled 'Evaluation of the usefulness of an intraoperative focus point automatic identification model using deep learning in laparoscopic cholecystectomy' on July 30.

Study Type: Observational

Primary Sponsor: Institute - The University of Tokyo hospital

Condition: Condition - Gallstone disease, Gallbladder polyps, Chronic cholecystitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In recent years, deep learning has attracted attention from researchers in engineering and medical fields, not only in the field of image recognition, due to its high performance and wide applicability compared to conventional algorithms.In our previous research, we developed a model that automatically predicts a surgeon's gaze point during surgery based on labeling data of anatomical structures and artificial objects in surgical videos. Specifically, in laparoscopic cholecystectomy, we noted that the tip of the right-hand forceps is often close to the surgeon's gaze point and devised an algorithm (new algorithm) that predicts the gaze point based on the historical position information of the right-hand forceps tip.Originally, one of the objectives of constructing a system to predict gaze points was to automate camera operations during laparoscopic surgery and reduce the human resources required by surgeons. To achieve this, we considered it useful to fix the laparoscopic camera externally and proceed with surgery while enlarging the gaze point. Furthermore, by combining this with technology that adjusts the enlarged field of view via voice input, we established a system that can be used in actual surgery.As we aim to introduce this system into clinical practice, the objective of this study is to evaluate the usefulness of the aforementioned new algorithm. While it is possible to perform surgery by simply tracking the tip of the right-hand forceps as the point of focus, the use of the new algorithm is expected to enable camera movements that more closely resemble those performed by surgeons during actual laparoscopic surgery. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - New patient cohort: Patients who undergo laparoscopic cholecystectomy at the Department of Hepatobiliary and Pancreatic Surgery and Organ Transplantation, The University of Tokyo Hospital, between the approval date and November 30, 2026, and who have provided informed consent.Specifically, this study excludes cases with severe gallbladder inflammation, such as acute cholecystitis following PTGBD or cholangitis with yellow granuloma, and instead focuses on cases with mild gallbladder inflammation, such as gallbladder polyps, gallstone disease, or mild chronic cholecystitis. Control group: Patients who underwent laparoscopic cholecystectomy at the Department of Hepatobiliary and Pancreatic Surgery, Tokyo University Hospital, between January 2008 and May 2025. The study focuses on cases with minimal gallbladder inflammation. Key exclusion criteria - Patients aged 17 years or younger. Patients who are unable to give consent. Patients who have previously undergone laparoscopic cholecystectomy and have refused to participate. Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 07 Month 17 Day Date of IRB - 2025 Year 07 Month 17 Day Anticipated trial start date - 2025 Year 07 Month 17 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066962

Disclaimer: Curated by HT Syndication.