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

NCT01268865 | Unknown DMC

• 1 other identifier: DMR99-IRB-240
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibrosis

Keywords

Acoustic Radiation Force Impulse (ARFI); Virtual Touch Quantification (VTQ); liver stiffness measurement (LSM); liver fibrosis; cirrhosis; hepatitis B; hepatitis C

Study Arms (2)

HBV-infected

HCV-infected

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HBV or HCV-infected patients about to undergo liver biopsy to assist in clinical decision making

You may qualify if:

• infected with HBV only or HCV only

You may not qualify if:

• concurrent HBV-HCV infection, etc.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Hepatitis B; Hepatitis C

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Sheng-Hung Chen, MD

  Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Cheng-Yuan Peng, MD, PhD

  Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

  STUDY DIRECTOR

Central Study Contacts

Sheng-Hung Chen, MD

CONTACT

886-4-22052121; shcvghtc@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: December 31, 2010
• Study Start: December 1, 2010
• Last Updated: June 3, 2011

Record last verified: 2011-06

Locations

TW (1)