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

Sponsor

Japan Liver Oncology Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT01360879

Collaborator

(none)

500

Enrollment

Location

Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B Chronic Hepatitis C

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2013

Anticipated Study Completion Date :

Sep 1, 2013

Outcome Measures

Primary Outcome Measures

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: liver fibrosis index diagnose of histological diagnosis F4 liver fibrosis index diagnose of histological diagnosis F3 or greater liver fibrosis index diagnose of histological diagnosis F2 or greater

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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