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Completed

NCT Number: NCT07297225

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Retrospective observational study without intervention measures

Other

Retrospective observational study without intervention measures

Primary outcomes

  1. Common bile duct FI / Liver background FI (C/L)

    Time frame: Perioperative period

    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.]

Secondary outcomes

  1. Qualitative assessment of fluorescence visualization

    Time frame: Perioperative period

    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)]

Other outcomes

  1. Preoperative laboratory test indicators and baseline data

    Time frame: Perioperative period

    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)]

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

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.

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