Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Chronic Liver Injury; Mindray Hepatus 9 Ultrasound Diagnostic System

Treatments: Other: Visual Transient Elastography (ViTE) Examination

Study type: Observational

Funder types: Other

Identifiers

NCT07128108

Hepatus-V1

Details and patient eligibility

About

Using liver biopsy as the gold standard, this study will conduct visual transient elastography (ViTE) examinations using Mindray Hepatus 9 ultrasound diagnostic system in patients with liver injury to evaluate the diagnostic efficacy of Liver Steatosis Analysis (LiSA) and ViTE for grading hepatic steatosis and fibrosis, and establish corresponding diagnostic thresholds.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be aged 18-65 years.
• Documented liver injury of any etiology with a liver biopsy performed within the past 2 weeks.
• Willing to undergo Visual Transient Elastography (ViTE) examination using Mindray Hepatus 9 Ultrasound System and capable of providing written informed consent.

Exclusion criteria

• Acute viral hepatitis.
• Right heart failure with either:Serum transaminases >5× upper limit of normal (ULN),Total bilirubin >85.5 μmol/L.
• History of hepatocellular carcinoma (HCC).
• Pregnancy.
• Patients with implantable medical devices.