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

NCT07551388 | Completed

• 1 other identifier: I-25PJ0054
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Cholecystitis

Outcome Measures

Primary Outcomes (1)

• Subjective Biliary Tract Visualization Quality Score

  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)

Study Arms (1)

Individualized ICG Fluorescence Cholangiography Arm

EXPERIMENTAL

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

Interventions

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.

Individualized ICG Fluorescence Cholangiography Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

• Li T, Lin C, Wang W. Global, regional, and national burden of pancreatic cancer from 1990 to 2021, its attributable risk factors, and projections to 2050: a systematic analysis of the global burden of disease study 2021. BMC Cancer. 2025 Feb 3;25(1):189. doi: 10.1186/s12885-025-13597-z.

  PMID: 39901108 BACKGROUND

• Li T, Zhao Y, Dong L, Han J, Zhao B, Lin C, Wang W. Preoperative Iron Isomaltoside administration enhances postoperative anemia recovery in robotic pancreatic surgery. J Robot Surg. 2026 Feb 7;20(1):227. doi: 10.1007/s11701-026-03176-0. No abstract available.

  PMID: 41653278 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 24, 2026
• Study Start: January 8, 2025
• Primary Completion: April 20, 2025
• Study Completion: October 31, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)