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COMPLETED
NCT07551388
NA

CBD Wall-Thickness Adjusted ICG Microdosing for Fluorescence Cholangiography in Moderate-to-Severe Acute Cholecystitis: A Single-Center Prospective Study

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2025-01-08

Completion Date

2025-10-31

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

DRUG

Indocyanine Green (ICG) Fluorescence Cholangiography

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China