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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03530657
• Other study ID #: STE/STQ 2018
• Status: Not yet recruiting
• Start date: June 4, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: May 2018
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 460
• Est. completion date: August 1, 2021
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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