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SWE Liver Stiffness as a Predictor of Progression of Chronic Liver Diseases (SWE Predict)

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ClinicalTrials.gov Identifier: NCT03389152
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
University of Bonn
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Liver Fibroses Device: Elastography

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of SWE as a Predictive Tool for Progression of Chronic Liver Diseases
Actual Study Start Date : February 1, 2010
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases


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


Primary Outcome Measures :
  1. Liver disease progression rate [ Time Frame: Minimum of 1 year follow-up ]
    Clinical signs of liver decompensation

  2. Mortality rate [ Time Frame: Minimum of 1 year follow-up ]
    Patient's death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Publications:
Responsible Party: SuperSonic Imagine
ClinicalTrials.gov Identifier: NCT03389152     History of Changes
Other Study ID Numbers: LE3
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At the end of the study, sharing of IPD will not be required.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Liver Diseases
Liver Cirrhosis
Digestive System Diseases