ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B

Study Overview
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Brief Summary
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This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.

Detailed Description
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Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique. ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis. This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard). The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed. Liver stiffness measurement made by the Aixplorer will also be compared to blood markers

Official Title
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Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection

Conditions
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Liver Fibrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection , Patients having reached the age of majority in China, Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the SWE measurement date, and having the recommended quality criterion: minimal length of biopsy samples of 15 mm, stored in paraffin Minimal number of portal tracts of 6 per biopsy samples Patients of Chinese ethnic origin Exclusion Criteria: Any patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection（Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc) History of antiviral therapy at any time Any patient presenting with a co-infection of HIV Any patient presenting with combined liver malignant tumor Previous liver transplantation Pregnant women Any patient with combined hepatic congestive condition such as Budd Chiari Syndrome, congestive heart failure, chronic constrictive pericarditis… Any patient combined with intrahepatic cholestasis

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 |
| --- | --- | --- |
| Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4). | This will be determined by histological examination of liver biopsy | Within 12 months of the study start date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, positive and negative predictive values of SWE to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4). | This will be determined by histological examination of liver biopsy | Within 12 months of the study start date | 

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