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

April 18, 2026 updated by: Weibin Wang, Peking Union Medical College Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized ICG Fluorescence Cholangiography Arm
All patients with moderate to severe acute cholecystitis undergoing emergency laparoscopic cholecystectomy receive an individualized, low-dose indocyanine green (ICG) injection. The ICG dose is calculated using a formula based on preoperative MRI-measured common bile duct wall thickness (0.012 + 0.0035625 × wall thickness, mg/kg), administered intravenously 1 hour before surgery. Near-infrared fluorescence cholangiography is performed during surgery to visualize the biliary anatomy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperatively (during emergency laparoscopic cholecystectomy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Actual)

April 20, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

April 18, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-25PJ0054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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