Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis

• Conditions: Liver Fibrosis

• Registration Number: NCT01268865
• Lead Sponsor: China Medical University Hospital

Brief Summary

Background: In patients with chronic liver diseases, liver fibrosis staging is crucial for hazard evaluation of future disease complication development and thus for the optimal decision making on treatment selections.In the era of antiviral and antifibrotic treatments, clinical and research demands are also increasing for non-invasive surveillance of liver fibrosis to evaluate the progression or regression. However, local baseline data on liver stiffness measurement (LSM) using ARFI technique is still lacking in Taiwan, where viral hepatitides are highly endemic. Aim: Using the ARFI elastosonography, we are dedicated to the aims to recruit patients based on strict but appropriate criteria, to complete the correlation and validity studies between ARFI quantification and the referenced METAVIR fibrosis scoring and to conduct subsequent innovative studies on liver diseases. Materials and Methods: We plan to perform the ARFI quantification for each HBV or HCV-infected patient immediately followed by priorly scheduled conventional liver biopsy for METAVIR scoring during the same session of examination. Statistics: The first year's study using ARFI will focus on the correlation testings and validity studies using receiver operating characteristics.

Detailed Description

Contribution and Future Works: Using the ARFI quantification either as a causal factor or as a outcome, we can conduct future analyses ranging from validations, regressions to prospective time-to-event analysis among our cohorts.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-30
• Study First Submitted QC: 2010-12-30
• Study First Posted: 2010-12-31
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-02
• Last Update Posted: 2011-06-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• infected with HBV only or HCV only

Exclusion Criteria

• concurrent HBV-HCV infection, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan