Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography

Study Overview
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Brief Summary
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This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements will predict prospectively the incidence of hepatocellular carcinoma, the incidence and severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C patients.

Detailed Description
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The aim of this study is to validate the predictive value of Real-time Tissue Elastography® by comparison with serum marker or FibroScan® in chronic hepatitis B or C patients. Every year and for three years, we performed Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy. If in the hospital they can perform FibroScan®, FobroScan® also be performed. Subjects were also performed ultrasonography (US), computed sonography (CT) or magnetic resonance imaging (MRI) evry four or six months. The time between the Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy and FiroScan® must not exceed four weeks.

Official Title
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Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography

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 Exclusion Criteria: Evidence or history of hepatocellular carcinoma History of alcohol abuse (alcohol intake > 20g/day) Pregnant or lactating patients Psychosis

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 |
| --- | --- | --- |
| Cumulative incidence of carcinogenesis of hepatocellular carcinoma | Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais | every four or six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-free survival | Cancer-free survival is defined as the time from registration to death due to cencer or any cause | every four or six months | 
| Overall survival | Overall survival is defined as the time from registration to death due to any cause | one year | 
| The cumulative incidence and severity of gastro-esophageal varices | It is estimated by gastrointestinal scope for every year | one year | 
| The cumulative incidence and severity of decompensated cirrhosis | Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis. | one year | 

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