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

NCT ID: NCT03389152

Last Updated: 2020-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-26

Study Completion Date

2019-11-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Fibroses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Elastography

liver stiffness measurements by shear wave-based elastography

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bonn

OTHER

Sponsor Role collaborator

SuperSonic Imagine

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28370257 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39437136 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LE3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.