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

December 8, 2025 updated by: Zhujiang Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.]
Perioperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)]
Perioperative period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)]
Perioperative period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-KY-323

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings