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

Z

Zhujiang Hospital

Status

Completed

Conditions

Cholecystitis
Cholelithiasis
MAFLD
Gallbladder Polyps

Treatments

Other: Retrospective observational study without intervention measures

Study type

Observational

Funder types

Other

Identifiers

NCT07297225
2025-KY-323

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

150 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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