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

NCT ID: NCT03530657

Last Updated: 2018-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-04

Study Completion Date

2021-08-01

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.

Conditions

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Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Rongqin Zheng

the Department of Medical Ultrasound

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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STE/STQ 2018

Identifier Type: -

Identifier Source: org_study_id

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