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

NCT ID: NCT01268865

Last Updated: 2011-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31

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.

Conditions

Liver Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HBV-infected

No interventions assigned to this group

HCV-infected

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• infected with HBV only or HCV only

Exclusion Criteria

• concurrent HBV-HCV infection, etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

China Medical University Hospital

Principal Investigators

Sheng-Hung Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

Cheng-Yuan Peng, MD, PhD

Role: STUDY_DIRECTOR

Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Sheng-Hung Chen, MD

Role: CONTACT

shcvghtc@gmail.com

886-4-22052121 ext. 2264

Facility Contacts

Sheng-Hung Chen, M.D.

Role: primary

shcvghtc@gmail.com

886-4-22052121 ext. 2264

Other Identifiers

DMR99-IRB-240

Identifier Type: -

Identifier Source: org_study_id