Assessment of Liver Fibrosis and Prognosis in Chinese Patients With CHB Infection Using STE/STQ Elastography

Study Overview
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Brief Summary
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This national multicenter prospective study is aimed to study the diagnositic performance of STE/STQ elastography in liver fibrosis and prognosis in patients with chronic hepatitis B infection.

Detailed Description
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Ultrasound liver elasticity measurement and imaging has not only been proposed as an alternative to evaluate the severity of chronic liver fibrosis, but also as a mean to stratify patients with advanced fibrosis according to risks of occurrence of clinical complications of end-stage liver diseases. Sound touch elastography (STE）and sound touch quantify (STQ) developed by Mindray Resona 7 imaging system provide both two-dimensional and point shear-wave elastography of tissue elasticity with stronger penetration and easy operation. This analysis will study the diagnositic performance of STE/STQ elastography for lver fibrosis and the prognostic value of STE/STQ elastography for the prediction of clinical complications of chronic liver diseases.

Official Title
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the Department of Medical Ultrasound, Third Affiliated Hospital of Sun Yat-Sen University

Conditions
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Cirrhosis

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 STE/STQ 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 of the conditions below will exclude patients from the study: Any patient presenting with combined etiologies of chronic liver diseases:，including Non hepatitis B viral infection（Hepatitis A, C, D, E）, alcoholic chronic liver disease, hemochromatosis, autoimmune hepatitis，etc Any patient presenting with a co-infection of HIV Any patient presenting with combined liver tumor Any patient ever received liver transplantation Pregnant women Acute hepatitis
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 |
| --- | --- | --- |
| Degree of Liver Fibrosis | All liver biopsies will be taken for evaluating the degree of liver fibrosis according to the METAVIRE classification. The degree of fibrosis is classified in a 0-4 scale as follows: F0: no fibrosis, F1: portal fibrosis alone, F2: portal fibrosis with rare septa, F3: portal fibrosis with many septa, and F4: cirrhosis. | 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates depending on liver STE/STQ measurement values at baseline | Clinical complications in our study protocol are: ascites, hepatic encephalopathy, esophageal varices, fundal varices, variceal bleeding, liver failure, HCC and death. The complication rates are regarded as occurrence of clinical complications in patients with chronic hepatitis B. | 2 years |