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

Kindai University

Status: Unknown

Conditions: Chronic Hepatitis B; Chronic Hepatitis C

Study type: Observational

Funder types: Other

Identifiers

NCT01360879

JLOG1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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