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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07297225
Enrollment
150
Registered
2025-12-22
Start date
2025-01-31
Completion date
2025-08-20
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Cholelithiasis, Gallbladder Polyps, MAFLD

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.

Interventions

OTHERRetrospective observational study without intervention measures

Retrospective observational study without intervention measures

Sponsors

Zhujiang Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Common bile duct FI / Liver background FI (C/L)Perioperative periodThe 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

MeasureTime frameDescription
Qualitative assessment of fluorescence visualizationPerioperative periodQualitative 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

MeasureTime frameDescription
Preoperative laboratory test indicators and baseline dataPerioperative periodHSI(Hepatic Steatosis Index) and FSI (Framingham Steatosis Index) \[Time Frame: Perioperative period\] \[Unit: Dimensionless number\] \[The variables included:ALT and AST(IU/L), BMI(kg/m2), gender(male/female), diabete(yes/no), age(years), TG (mmol/L), Hypertension(yes/no)\]

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026