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Accuracy of RTE for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02143180
Collaborator
(none)
500
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Our study is a prospective multicenter research and the aim is to explore a variety of suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get the corresponding diagnosis threshold, with the domestic common pathological S stages as the gold standard.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Time Perspective:
    Prospective
    Official Title:
    Accuracy of Real-time Tissue Elastography for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study.
    Study Start Date :
    May 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Liver Fibrosis Index (LFI) [During the examination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Patient has a history of chronic hepatitis on clinical diagnosis; 2. Patient undergoed liver biopsy during study time.
    Exclusion Criteria:
      1. Patient cannot receive examination due to critical condition; 2. Patient refuse the examination.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The department of Ultrasound, the third affiliated hospital of Sun Yat-son University Guangzhou Guangdong China

    Sponsors and Collaborators

    • Third Affiliated Hospital, Sun Yat-Sen University

    Investigators

    • Principal Investigator: Rogqin RQ Zheng, doctor, The department of Ultrasound, the third affiliated hospital of Sun Yat-son University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rongqin Zheng, professor, Third Affiliated Hospital, Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT02143180
    Other Study ID Numbers:
    • ThirdSunYatSen
    First Posted:
    May 20, 2014
    Last Update Posted:
    May 20, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Rongqin Zheng, professor, Third Affiliated Hospital, Sun Yat-Sen University
    real-time tissue elastography
    hepatic fibrosis
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis
    Hepatitis, Chronic
    Fibrosis

    Study Results

    No Results Posted as of May 20, 2014