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

Liver Fibrosis Clinical Trial

— ARFI  

Official title:

Clinical Application of Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis in HBV and HCV-infected Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01268865
• Other study ID #: DMR99-IRB-240
• Status: Recruiting
• Phase: N/A
• First received: December 30, 2010
• Last updated: June 2, 2011
• Start date: December 2010

Study information

• Verified date: June 2011
• Source: China Medical University Hospital
• Contact: Sheng-Hung Chen, MD
• Phone: 886-4-22052121
• Email: shcvghtc[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• infected with HBV only or HCV only

Exclusion Criteria:

• concurrent HBV-HCV infection, etc.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan,