Skip to main content
OpenTrials
Completed

NCT Number: NCT07551388

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥18 years undergoing emergency laparoscopic cholecystectomy.
  • Diagnosis of moderate to severe acute cholecystitis according to the 2018 Tokyo Guidelines.
  • Preoperative MRI available for common bile duct wall thickness measurement.
  • Ability to provide informed consent.

Exclusion criteria

  • Known allergy or contraindication to indocyanine green (ICG).
  • Severe renal or hepatic dysfunction (eGFR <30 mL/min/1.73m² or Child-Pugh class B/C cirrhosis).
  • Pregnancy or breastfeeding.
  • Previous biliary surgery or known choledocholithiasis requiring preoperative intervention.
  • Unstable hemodynamic status requiring conversion to open surgery before ICG administration.

Treatment and study plan

Indocyanine Green (ICG) Fluorescence Cholangiography

Drug

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.

Primary outcomes

  1. Subjective Biliary Tract Visualization Quality Score

    Time frame: Intraoperatively (during emergency laparoscopic cholecystectomy)

    Intraoperative assessment of biliary tract visualization quality using a 4-point subjective scale (1=poor, 2=fair, 3=good, 4=excellent). The score is assigned by the operating surgeon based on the clarity of the cystic duct and common bile duct fluorescence signals, with a primary endpoint of achieving a mean score of ≥3.0 across all enrolled patients.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.