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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01360879

Acronym

FIBROELAST

Enrollment

500

Registered

2011-05-26

Start date

2010-09-30

Completion date

2013-09-30

Last updated

2011-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B, Chronic Hepatitis C

Keywords

Hepatitis B virus, Hepatitis C virus, Chronic hepatitis, Liver cirrhosis, Liver stiffness, Liver fibrosis

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Japan

Contacts

Primary ContactNorihisa Yada, M.D.

yada@med.kindai.ac.jp+81-72-366-0221

Backup ContactKazuomi Ueshima, M.D.

kaz-ues@med.kindai.ac.jp+81-72-366-0221

Outcome results