Liver Fibrosis Assessment With ShearWave Elastography

Study Overview
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Brief Summary
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Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to measure the stiffness of organs in the body, for example the liver. This study will evaluate how this technology performs as a non-invasive test to stage liver fibrosis in patients with chronic liver disease.

Detailed Description
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The measurements of liver stiffness made by the Aixplorer® will be compared to (where available) : blood markers biopsy results other stiffness measurement exams (FibroScan, ARFI, ElastPQ...) The influence of other (confounding) factors on the reliability of SWE measurements will be analyzed.

Official Title
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Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases

Conditions
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Liver Fibrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients meeting a single condition below: Chronic hepatitis B, defined by serology HBsAg positive and the presence of DNA / RNA in the serum, or Chronic hepatitis C, defined by serology anti-HCV positive and the presence of DNA / RNA in the serum, or non-alcoholic fatty-liver disease And meeting all of the conditions below: liver biopsy for histological evaluation of liver fibrosis Length of liver biopsy ≥ 15 mm paraffin sections (except if cirrhosis) Age of majority in their country Obtaining the signature of consent for participation in the data collection, in addition to the routine consent form routinely used at the sites. Exclusion Criteria: Cause of chronic liver disease other than viral (alcohol, hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...) and other than non-alcoholic fatty-liver disease History of antiviral therapy for 6 months or less of current antiviral therapy Any systemic, viral hepatitis and HIV co-infection Pregnant woman Failure to obtain consent Length of all liver biopsy specimens below 15mm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficients between factors and liver stiffness | Factors include patient's clinical and biological parameters | Within one year of the study start date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rates depending on factors | Factors include patient's clinical and biological parameters | Within one year of the study start date | 
| Diagnostic performance of multivariate models to assess liver fibrosis levels | Determined by histological examination of liver biopsy. The resulting tests will be compared on the basis of their AUROC and test of statistical differences. Fibrosis levels involved are: at least significant fibrosis (Metavir score F≥2) at least severe fibrosis (Metavir score F≥3) liver cirrhosis (Metavir score F=4) | Within one year of the study start date | 
| Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis | This will be determined by histological examination of liver biopsy | Within one year of the study start date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver, fibrosis, ShearWave Elastography, ultrasound