SWE Liver Stiffness as a Predictor of Progression of Chronic Liver Diseases

Completed

• Conditions: Liver Fibroses

• Registration Number: NCT03389152
• Lead Sponsor: SuperSonic Imagine

Brief Summary

This study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (SSI-SWE) in patients with liver fibrosis to predict progression of chronic liver disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-26
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-03
• Primary Completion: 2018-01-09
• Study Completion: 2019-11-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2148

Inclusion Criteria

• Patients who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease of viral and/or steatotic origin,
• Patients who had reached the age of majority in their countries, at baseline,
• Patients with a baseline liver biopsy for histological evaluation of liver fibrosis with a length ≥ 15 mm paraffin sections (except if cirrhosis),
• Patients for whom a minimum length of clinical follow-up from baseline of 1 year had been recorded

Exclusion Criteria

• Cause of chronic liver disease other than viral, ALD or NAFLD ( hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...)
• Any systemic, viral hepatitis and HIV co-infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Liver disease progression rate	Minimum of 28 days follow-up	Clinical signs of liver decompensation
Mortality rate	Minimum of 28 days follow-up	Patient's death