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

NCT07297225 | Completed

• 1 other identifier: 2025-KY-323
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MAFLD; Cholecystitis; Gallbladder Polyps; Cholelithiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Qualitative assessment of fluorescence visualization

  Perioperative period

Other Outcomes (1)

• Preoperative laboratory test indicators and baseline data

  Perioperative period

Study Arms (4)

Non-MAFLD Group

Other: Retrospective observational study without intervention measures

MAFLD Group

Other: Retrospective observational study without intervention measures

Training Cohort

Other: Retrospective observational study without intervention measures

Validation Cohort

Other: Retrospective observational study without intervention measures

Interventions

Retrospective observational study without intervention measures OTHER

Retrospective observational study without intervention measures

MAFLD Group; Non-MAFLD Group; Training Cohort; Validation Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

MeSH Terms

Conditions

Cholecystitis; Cholelithiasis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: December 22, 2025
• Study Start: January 31, 2025
• Primary Completion: May 30, 2025
• Study Completion: August 20, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-07

Locations

CN (1)