Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease

NCT ID: NCT01360879

Last Updated: 2011-05-26

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-09-30

Brief Summary

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This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.

Detailed Description

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The aim of this study is to validate the diagnostic value of Real-time Tissue Elastography® by comparison with liver histology, serum marker or FibroScan® in chronic hepatitis B or C patients.Real-time Tissue Elastography®, biopsy and serum maker are performed.

If in the hospital they can perform FibroScan®, FobroScan® also be performed. The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least six months. The time between the Real-time Tissue Elastography® , biopsy, blood sampling and FiroScan® must not exceed four weeks.

Conditions

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Chronic Hepatitis B Chronic Hepatitis C

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male or female and at least 20 years of age
* Chronic hepatitis B or Chronic hepatitis C
* Subject is willing to fast for 8 hours prior to each study visit

Exclusion Criteria

* History of alcohol abuse (alcohol intake \> 20g/day)
* Evidence or history of chronic hepatitis not caused by HBV or HCV
* During 6 months before registration to this trial has completed, nucleic acid analogue preparations or interferon therapy was performed.
* Pregnant or lactating patients
* Contraindications of liver biopsy or liver resection
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kindai University

OTHER

Sponsor Role lead

Responsible Party

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Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine

Principal Investigators

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Masatoshi Kudo, Professor

Role: STUDY_CHAIR

Kinki University Faculty of Medicine

Locations

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Kinki University Faculty of Medicine

Ōsaka-sayama, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Norihisa Yada, M.D.

Role: CONTACT

+81-72-366-0221 ext. 3525

Kazuomi Ueshima, M.D.

Role: CONTACT

+81-72-366-0221 ext. 3525

Facility Contacts

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Norihisa Yada, MD

Role: primary

+81-72-366-0221 ext. 3525

Kazuomi Ueshima, MD

Role: backup

+81-72-366-0221 ext. 3525

Other Identifiers

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JLOG1002

Identifier Type: -

Identifier Source: org_study_id

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