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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03389152
Other study ID # LE3
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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