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

Recruiting

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

• Registration Number: NCT07128108
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC).	baseline	Optimal cutoff values for LiSA and ViTE were determined by maximizing the Youden index, sensitivity (Se), and specificity (Sp). For each cutoff value, the following metrics with 95% confidence intervals (CI) were calculated: sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV).

Trial Locations

Locations (1)

XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China