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

NCT03389152 | Completed FDA Device

• 1 other identifier: LE3
• Study Type: observational
• Target: 2,148
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Fibroses

Outcome Measures

Primary Outcomes (2)

• Liver disease progression rate

  Clinical signs of liver decompensation

  Minimum of 28 days follow-up

• Mortality rate

  Patient's death

  Minimum of 28 days follow-up

Interventions

Elastography DEVICE

liver stiffness measurements by shear wave-based elastography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected or confirmed chronic liver disease of viral and/or steatotic origin, requiring a percutaneous liver biopsy, and who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SuperSonic Imagine: lead
• University of Bonn: collaborator

Related Publications (2)

• Herrmann E, de Ledinghen 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.

  PMID: 28370257 BACKGROUND

• Gu W, de Ledinghen V, Aube C, Krag A, Strassburg C, Castera L, Dumortier J, Friedrich-Rust M, Pol S, Grgurevic I, Zeleke Y, Praktiknjo M, Schierwagen R, Klein S, Francque S, Gottfriedova H, Sporea I, Schindler P, Rennebaum F, Brol MJ, Schulz M, Uschner FE, Fischer J, Margini C, Wang W, Delamarre A, Best J, Canbay A, Bauer DJM, Simbrunner B, Semmler G, Reiberger T, Boursier J, Rasmussen DN, Vilgrain V, Guibal A, Zeuzem S, Vassord C, Vonghia L, Senkerikova R, Popescu A, Berzigotti A, Laleman W, Thiele M, Jansen C, Trebicka J. Hepatocellular Cancer Surveillance in Patients with Advanced Chronic Liver Disease. NEJM Evid. 2024 Nov;3(11):EVIDoa2400062. doi: 10.1056/EVIDoa2400062. Epub 2024 Oct 22.

  PMID: 39437136 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 3, 2018
• Study Start: July 26, 2007
• Primary Completion: January 9, 2018
• Study Completion: November 28, 2019
• Last Updated: July 27, 2020

Record last verified: 2020-07