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Completed

NCT Number: NCT03389152

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elastography

Device

liver stiffness measurements by shear wave-based elastography

Primary outcomes

  1. Liver disease progression rate

    Time frame: Minimum of 28 days follow-up

    Clinical signs of liver decompensation

  2. Mortality rate

    Time frame: Minimum of 28 days follow-up

    Patient's death

Sponsors and collaborators

Lead sponsor

SuperSonic Imagine

Industry

Collaborators

  • University of Bonn

Registry information

Official study title

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

Acronym: SWE Predict

Important dates

Study start
2007
Primary completion
2018
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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