Metabolic Dysfunction-Associated Fatty Liver Disease Impairs Intraoperative Indocyanine Green Fluorescence Cholangiography Quality: Development and Validation of a Predictive Model

Near-infrared fluorescence cholangiography has been shown to improve the clinical outcomes of laparoscopic cholecystectomy (LC). However, it remains unclear whether hepatic steatosis in patients with metabolic dysfunction-associated fatty liver disease (MAFLD) influences the quality of indocyanine green fluorescence imaging (ICG-FI), and whether the quality can be predicted preoperatively. This study aimed to evaluate the impact of MAFLD on intraoperative fluorescence quality and to develop a multiple linear regression model for predicting intraoperative ICG-FI.

Study Overview

• Status: Completed
• Conditions: Cholecystitis; Cholelithiasis; Gallbladder Polyps; MAFLD
• Intervention / Treatment: Other: Retrospective observational study without intervention measures

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

(1) Age 18-75 years, any sex; (2) Definite surgical indication for cholecystectomy; (3) Underwent LC; (4) No severe contraindications such as significant cardiac, pulmonary, renal, or cerebral dysfunction.

Description

Inclusion Criteria:

1. Age 18-75 years, any sex;
2. Definite surgical indication for cholecystectomy;
3. Underwent LC;
4. No severe contraindications such as significant cardiac, pulmonary, renal, or cerebral dysfunction.

Exclusion Criteria:

1. Known allergy to ICG or iodinated contrast agents;
2. Use of medications affecting biliary excretion within 2 weeks prior to surgery; (3) LC without ICG-FI;

(4) Incomplete clinical data.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-MAFLD Group	Other: Retrospective observational study without intervention measures; Retrospective observational study without intervention measures
MAFLD Group	Other: Retrospective observational study without intervention measures; Retrospective observational study without intervention measures
Training Cohort	Other: Retrospective observational study without intervention measures; Retrospective observational study without intervention measures
Validation Cohort	Other: Retrospective observational study without intervention measures; Retrospective observational study without intervention measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Common bile duct FI / Liver background FI (C/L)	The common bile duct-to-liver background fluorescence intensity ratio (C/L) [Unit: Dimensionless number] [Time Frame: Perioperative period] [Measurement steps: Three photographs per case were obtained with the following requirements: Calot's triangle centred in the image, liver background positioned superiorly, and the CBD inferiorly, ensuring all measurement sites were visible and unobstructed. Each image was converted to greyscale, and regions of interest (ROI) of >3000 pixels were selected for each critical structure to calculate FI. The mean FI from the three images was recorded as the final value for each structure.]	Perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of fluorescence visualization	Qualitative assessment of fluorescence visualization. [Time Frame: Perioperative period] [Unit: Dimensionless number] [Measurement steps: It was performed by three senior surgeonsScores were averaged and graded on a five-point scale adapted from previous studies (1=completely invisible, impairs visualization; 2=poor, faint fluorescence, no added value; 3= visible but blurred, some added value; 4=good, clear visualization with significant added value; 5= excellent, very clear visualization with typical added value)]	Perioperative period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative laboratory test indicators and baseline data	HSI（Hepatic Steatosis Index) and FSI (Framingham Steatosis Index) [Time Frame: Perioperative period] [Unit: Dimensionless number] [The variables included：ALT and AST(IU/L), BMI(kg/m2), gender(male/female), diabete(yes/no), age(years), TG (mmol/L), Hypertension(yes/no)]	Perioperative period

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): August 20, 2025

Study Registration Dates

• First Submitted: September 21, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Cholelithiasis
• Other Study ID Numbers: 2025-KY-323