UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058609 |
|---|---|
| Receipt number | R000066962 |
| Scientific Title | Evaluation of the usefulness of an intraoperative focus point automatic identification model using deep learning in laparoscopic cholecystectomy |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2025/07/27 09:48:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the usefulness of an intraoperative focus point automatic identification model using deep learning in laparoscopic cholecystectomy
Acronym
Evaluation of the usefulness of an intraoperative focus point automatic identification model using deep learning in laparoscopic cholecystectomy
Scientific Title
Evaluation of the usefulness of an intraoperative focus point automatic identification model using deep learning in laparoscopic cholecystectomy
Scientific Title:Acronym
Evaluation of the usefulness of an intraoperative focus point automatic identification model using deep learning in laparoscopic cholecystectomy
Region
| Japan |
Condition
Condition
Gallstone disease, Gallbladder polyps, Chronic cholecystitis
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will compare the times deemed appropriate and inappropriate for surgical videos for each video and evaluate the usefulness of the new algorithm and select the most appropriate algorithm. We will also compare postoperative outcomes such as the length of hospital stay including patient information, the incidence of complications within 30 days, and the readmission rate within 90 days.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hasegawa |
Organization
The University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kihase-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Oikawa |
Organization
The University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
oikawar-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1 This study includes patients who were determined to be eligible for laparoscopic cholecystectomy within the scope of routine clinical practice at the Department of Hepatobiliary and Pancreatic Surgery and Artificial Organ Transplantation, Tokyo University Hospital.
2 Prior to the procedure, patients undergoing the surgery will receive preoperative explanations about the procedure and obtain informed consent. Following this, they will be informed about the study and obtain informed consent for participation.
3 The surgery will be performed by the surgeon, assistant, and laparoscopic surgeon as usual. Two monitors will be used, with one displaying the standard camera view and the other showing real-time magnification of the right-hand forceps tip.
4 After port insertion and adhesion separation are completed, and the standard cholecystectomy technique is initiated, the surgeon will fix the scope using an external scope holder and proceed with the surgery while viewing the magnified image of the right-hand forceps tip or fixed images as needed, starting from approximately 5 minutes after the initiation of the cystic duct neck processing and approximately 5 minutes after the division of the cystic duct and cystic artery.During all other times, the scope operator operates the scope as usual to proceed with the surgery.
5 After surgery, the enlarged images from the right-hand forceps tip and the fixed images are recorded. By applying a new algorithm with multiple patterns to the fixed images, additional enlarged images are created.
6 While the surgeon reviews the surgical video, they are asked to continuously press a button at their fingertips during scenes deemed inappropriate as the surgical field and release it during appropriate scenes.
7 Compare the times deemed appropriate or inappropriate for each video to evaluate the usefulness of the new algorithm and select the most suitable algorithm.
Management information
Registered date
| 2025 | Year | 07 | Month | 27 | Day |
Last modified on
| 2025 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066962
