Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 225
- Locations
- 2
- Primary Endpoint
- The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC).
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC).
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported