CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Indocyanine Green (ICG) Fluorescence Cholangiographydrug
Likely dose
Not stated in record
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Search/NCT07551388
NCT07551388N/ACompleted

Optimal Weight-Based Indocyanine Green Dosage for Fluorescent Cholangiography in Laparoscopic Cholecystectomy Among Chinese Population:Construction and Validation

Peking Union Medical College Hospital·interventional·Posted Apr 24, 2026·Updated Apr 24, 2026

In Brief

A clinical study evaluating Indocyanine Green (ICG) Fluorescence Cholangiography for Acute Cholecystitis. Completed, enrolled 21 participants across 1 site.

Detailed Summary

This is a single-center prospective study designed to develop and validate an individualized, low-dose indocyanine green (ICG) protocol for near-infrared fluorescence cholangiography during emergency laparoscopic cholecystectomy in patients with moderate to severe acute cholecystitis. The main problem we aim to solve is that inflammation in the bile duct wall often makes standard ICG doses ineffective for clear visualization. We will use pre-operative MRI to measure the thickness of the common bile duct (CBD) wall, then calculate a personalized ICG dose using a simple formula. We will first test and refine this formula in a small group of patients, then verify its effectiveness in a second group. The goal is to achieve clear, high-contrast imaging of the bile ducts, which helps surgeons operate more safely and accurately. All patients will receive a low, personalized dose of ICG given by vein 1 hour before surgery. We will evaluate how well the bile ducts show up on the fluorescence images, as well as safety and effectiveness outcomes. This study will provide a practical, patient-tailored solution for improving bile duct visualization in emergency gallbladder surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedApr 24, 2026
Enrollment StartJan 8, 2025
Primary CompletionApr 20, 2025
Study CompletionOct 31, 2025
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2 months ago

Interventions

Indocyanine Green (ICG) Fluorescence Cholangiographydrug

Indocyanine green (ICG) is administered intravenously 1 hour before emergency laparoscopic cholecystectomy. The dose is individualized based on preoperative MRI-measured common bile duct wall thickness using the formula: 0.012 + 0.0035625 × wall thickness (mg/kg). Near-infrared fluorescence cholangiography is performed intraoperatively to visualize the biliary anatomy.