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

Liver Fibroses Clinical Trial

— SWE Predict  

Official title:

Evaluation of SWE as a Predictive Tool for Progression of Chronic Liver Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389152
• Other study ID #: LE3
• Status: Completed
• Start date: July 26, 2007
• Est. completion date: November 28, 2019

Study information

• Verified date: July 2020
• Source: SuperSonic Imagine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2148
• Est. completion date: November 28, 2019
• Est. primary completion date: January 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Diseases
• Liver Fibroses

Intervention

Device:
• Elastography
liver stiffness measurements by shear wave-based elastography

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SuperSonic Imagine	University of Bonn

References & Publications (1)

Herrmann E, de Lédinghen V, Cassinotto C, Chu WC, Leung VY, Ferraioli G, Filice C, Castera L, Vilgrain V, Ronot M, Dumortier J, Guibal A, Pol S, Trebicka J, Jansen C, Strassburg C, Zheng R, Zheng J, Francque S, Vanwolleghem T, Vonghia L, Manesis EK, Zoumpoulis P, Sporea I, Thiele M, Krag A, Cohen-Bacrie C, Criton A, Gay J, Deffieux T, Friedrich-Rust M. Assessment of biopsy-proven liver fibrosis by two-dimensional shear wave elastography: An individual patient data-based meta-analysis. Hepatology. 2018 Jan;67(1):260-272. doi: 10.1002/hep.29179. Epub 2017 Nov 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver disease progression rate	Clinical signs of liver decompensation	Minimum of 28 days follow-up
Primary	Mortality rate	Patient's death	Minimum of 28 days follow-up