Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease

Study Overview
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Brief Summary
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This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.

Detailed Description
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The aim of this study is to validate the diagnostic value of Real-time Tissue Elastography® by comparison with liver histology, serum marker or FibroScan® in chronic hepatitis B or C patients.Real-time Tissue Elastography®, biopsy and serum maker are performed. If in the hospital they can perform FibroScan®, FobroScan® also be performed. The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least six months. The time between the Real-time Tissue Elastography® , biopsy, blood sampling and FiroScan® must not exceed four weeks.

Official Title
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Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease

Conditions
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Chronic Hepatitis B, Chronic Hepatitis C

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female and at least 20 years of age Chronic hepatitis B or Chronic hepatitis C Subject is willing to fast for 8 hours prior to each study visit Exclusion Criteria: History of alcohol abuse (alcohol intake > 20g/day) Evidence or history of chronic hepatitis not caused by HBV or HCV During 6 months before registration to this trial has completed, nucleic acid analogue preparations or interferon therapy was performed. Pregnant or lactating patients Contraindications of liver biopsy or liver resection

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- | --- |
| Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis | To evaluate the correlation between Real-time Tissue Elastography® index and histological diagnosis (the gold standard for liver fibrosis), we calculate sensitivity and specificity, ROC curves. Sensitivity, specificity and ROC curves obtained under below stiations: liver fibrosis index diagnose of histological diagnosis F4 liver fibrosis index diagnose of histological diagnosis F3 or greater liver fibrosis index diagnose of histological diagnosis F2 or greater | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker | To evaluate the correlation between Real-time Tissue Elastography® index and serum markers of hepatic fibrosis, we estimate Pearson correlation coefficient of each request. | one year | 
| Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan® | To evaluate the correlation between Real-time Tissue Elastography® index and FibroScan® index, we estimate Pearson correlation coefficient of each request. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C virus, Hepatitis B virus, Chronic hepatitis, Liver cirrhosis, Liver stiffness, Liver fibrosis