A Clinical Study of Ultrasound-derived Fat Fraction to Assess Metabolic Dysfunction-Associated Steatotic Liver Disease

NCT06487325 | Completed

• 1 other identifier: YXLL-KY-2024(014)
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Aims: To evaluate the diagnostic performance of ultrasound-derived fat fraction (UDFF) in assessing the degree of hepatic steatosis in an obese population, with liver biopsy as reference standard. Materials and methods: Obese individuals, who were found to have fatty liver by B-mode ultrasound and underwent UDFF measurement, along with liver biopsy results, were retrospectively selected from The First Affiliated Hospital of Shandong First Medical University.The inclusion criteria were as follows: (1) BMI over 30 kg/m²; (2) diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional B-mode ultrasound; (3) serologic test results were available. The exclusion criteria include: (1) patients who have undergone liver resection or have liver space-occupying lesions; (2) pregnant women; (3) patients with incomplete medical history data.

Conditions

Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• UDFF values

  During the examination, the DAX probe was positioned in the right intercostal space, and the UDFF mode was selected to place a fixed-size region of interest (ROI) vertically in the right lobe of the liver, 1.5 cm away from the liver capsule, avoiding the intrahepatic duct structure. Measurements were acquired after the patient maintained a calm breathing pattern, and the system automatically determined the shear wave velocity (Vs), elastic modulus (E), and UDFF values.

  up to 1 year

Secondary Outcomes (1)

• SWE values

  up to 1 year

Study Arms (3)

Group S1

Liver biopsy showed mild fatty liver

Group S2

Liver biopsy showed moderate fatty liver

Group S3

Liver biopsy showed severe fatty liver

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese individuals, who were found to have fatty liver by B-mode ultrasound and underwent UDFF measurement, along with liver biopsy results, were retrospectively selected from The First Affiliated Hospital of Shandong First Medical University

You may qualify if:

• BMI over 30 kg/m²
• diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional B-mode ultrasound
• serologic test results were available

You may not qualify if:

• patients who have undergone liver resection or have liver space-occupying lesions
• pregnant women
• patients with incomplete medical history data

Sponsors & Collaborators

• Ma Zhe: lead

Study Sites (1)

QianfoshanH

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Ultrasound

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 5, 2024
• Study Start: April 29, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)