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

Sponsor

China Medical University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01268865

Collaborator

(none)

200

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Fibrosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
HBV-infected
HCV-infected

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

infected with HBV only or HCV only

Exclusion Criteria:

concurrent HBV-HCV infection, etc.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University Hospital	Taichung		Taiwan	40447

Sponsors and Collaborators

China Medical University Hospital

Investigators

Principal Investigator: Sheng-Hung Chen, MD, Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
Study Director: Cheng-Yuan Peng, MD, PhD, Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital