Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061699) titled 'A Prospective Study Evaluating the Safety and Utility of ICG Fluorescence-Guided Biliary Navigation Surgery' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - International University of Health and Welfare
Condition:
Condition - Biliary diseases and hepatobiliary-pancreatic tumors requiring hepatobiliary surgery
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to prospectively evaluate the safety and feasibility of fluorescence-guided biliary navigation using direct intrabiliary or intracholecystic injection of indocyanine green (ICG). In particular, this study aims to assess the utility of this technique for intraoperative visualization of biliary anatomy, identification of bile leakage sites, and surgical navigation during hepatobiliary procedures.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Diluted indocyanine green (ICG) solution will be directly injected into the bile duct or gallbladder during surgery, followed by near-infrared fluorescence imaging for biliary visualization. Injection will be performed through an ENBD tube, gallbladder puncture, or biliary tube as appropriate.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients scheduled to undergo hepatobiliary surgery at International University of Health and Welfare Narita Hospital
2. Cases considered suitable for intraoperative biliary navigation
3. Patients who provide written informed consent after receiving sufficient explanation regarding the study
Key exclusion criteria - 1. Patients with a history of hypersensitivity to ICG or iodine
2. Pregnant patients or patients with possible pregnancy
3. Patients with severe hepatic dysfunction or poor general condition
4. Patients deemed unsuitable for study participation by the principal investigator
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 26 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070602
Disclaimer: Curated by HT Syndication.
