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

NCT ID: NCT07297225

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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MAFLD Cholecystitis Gallbladder Polyps Cholelithiasis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-MAFLD Group

Retrospective observational study without intervention measures

Intervention Type OTHER

Retrospective observational study without intervention measures

MAFLD Group

Retrospective observational study without intervention measures

Intervention Type OTHER

Retrospective observational study without intervention measures

Training Cohort

Retrospective observational study without intervention measures

Intervention Type OTHER

Retrospective observational study without intervention measures

Validation Cohort

Retrospective observational study without intervention measures

Intervention Type OTHER

Retrospective observational study without intervention measures

Interventions

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Retrospective observational study without intervention measures

Retrospective observational study without intervention measures

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2025-KY-323

Identifier Type: -

Identifier Source: org_study_id