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

• Conditions: Chronic Hepatitis C; Chronic Hepatitis B

• Registration Number: NCT01360879
• Lead Sponsor: Kindai University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-08
• Study Start: 2010-09
• Study First Submitted: 2011-05-21
• Study First Submitted QC: 2011-05-25
• Last Update Submitted: 2011-05-25
• Study First Posted: 2011-05-26
• Last Update Posted: 2011-05-26
• Primary Completion: 2013-08
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis	one year	To evaluate the correlation between Real-time Tissue Elastography® index and histological diagnosis (the gold standard for liver fibrosis), we calculate sensitivity and specificity, ROC curves.; Sensitivity, specificity and ROC curves obtained under below stiations: 1. liver fibrosis index diagnose of histological diagnosis F4; 2. liver fibrosis index diagnose of histological diagnosis F3 or greater; 3. liver fibrosis index diagnose of histological diagnosis F2 or greater

Secondary Outcome Measures

Name	Time	Method
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker	one year	To evaluate the correlation between Real-time Tissue Elastography® index and serum markers of hepatic fibrosis, we estimate Pearson correlation coefficient of each request.
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan®	one year	To evaluate the correlation between Real-time Tissue Elastography® index and FibroScan® index, we estimate Pearson correlation coefficient of each request.

Trial Locations

Locations (1)

Kinki University Faculty of Medicine; 🇯🇵 Osaka-sayama, Osaka, Japan