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

• Conditions: Cirrhosis

• Registration Number: NCT03530657
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-04-20
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-08
• Last Update Submitted: 2018-05-08
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21
• Study Start: 2018-06-04
• Primary Completion: 2020-06-04
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of Liver Fibrosis	1-2 years	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.

Secondary Outcome Measures

Name	Time	Method
Complication rates depending on liver STE/STQ measurement values at baseline	2 years	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.