ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B

April 18, 2016 updated by: SuperSonic Imagine

Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection

This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.

Study Overview

Status

Completed

Conditions

Detailed Description

Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique.

ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis.

This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard).

The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed.

Liver stiffness measurement made by the Aixplorer will also be compared to blood markers

Study Type

Observational

Enrollment (Actual)

447

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • People's Liberation Army General（301）Hospital
      • Chengdu, China
        • West China Hospital, Sichuan University
      • GuangZhou, China
        • 1st Affiliated Hospital, Sun Yat-Sen University
      • GuangZhou, China
        • Guangzhou 8th People's Hospital
      • Guangzhou, China
        • 3rd Affiliated Hospital, Sun Yat-Sen University
      • Haerbin, China
        • 1st Affiliated Hospital, Haerbin Medical University
      • HangZhou, China
        • 1st Affiliated Hospital, ZheJiang University
      • KunMing, China
        • YunNan Province Second People's Hospital
      • LanZhou, China
        • 2nd Affiliated Hospital, Lanzhou University
      • NanJing, China
        • Jiangsu Provincial Hospital
      • Shanghai, China
        • Shanghai 1st People's Hospital
      • ShenYang, China
        • Shengjing Hospital of Chinese Medical University
      • XiAn, China
        • 1st Affiliated Hospital, XiAn Transportation University
      • XiAn, China
        • Xijing Hospital
      • ZhengZhou, China
        • Isolation Hospital, HeNan Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese patients with chronic viral hepatitis B admitted for the realization of an intercostal liver biopsy in defined investigator centers.

Description

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 SWE 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 patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection（Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc)
  • History of antiviral therapy at any time
  • Any patient presenting with a co-infection of HIV
  • Any patient presenting with combined liver malignant tumor
  • Previous liver transplantation
  • Pregnant women
  • Any patient with combined hepatic congestive condition such as Budd Chiari Syndrome, congestive heart failure, chronic constrictive pericarditis…
  • Any patient combined with intrahepatic cholestasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).
Time Frame: Within 12 months of the study start date
This will be determined by histological examination of liver biopsy
Within 12 months of the study start date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, positive and negative predictive values of SWE to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).
Time Frame: Within 12 months of the study start date
This will be determined by histological examination of liver biopsy
Within 12 months of the study start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SuperSonic Imagine

Investigators

  • Principal Investigator: Ping Liang, People's Liberation Army General（301）Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LE2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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