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Trial record 1 of 1 for:    NCT01268865
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Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis (ARFI)

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ClinicalTrials.gov Identifier: NCT01268865
Recruitment Status : Unknown
Verified June 2011 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2010
Last Update Posted : June 3, 2011
Sponsor:
Information provided by:

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
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
Estimated 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 : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
HBV-infected
HCV-infected


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HBV or HCV-infected patients about to undergo liver biopsy to assist in clinical decision making
Criteria

Inclusion Criteria:

  • infected with HBV only or HCV only

Exclusion Criteria:

  • concurrent HBV-HCV infection, etc.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268865


Contacts
Contact: Sheng-Hung Chen, MD 886-4-22052121 ext 2264 shcvghtc@gmail.com

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Sheng-Hung Chen, M.D.    886-4-22052121 ext 2264    shcvghtc@gmail.com   
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
More Information

Responsible Party: Sheng-Hung Chen, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01268865     History of Changes
Other Study ID Numbers: DMR99-IRB-240
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: June 3, 2011
Last Verified: June 2011

Keywords provided by China Medical University Hospital:
Acoustic Radiation Force Impulse (ARFI)
Virtual Touch Quantification (VTQ)
liver stiffness measurement (LSM)
liver fibrosis
cirrhosis
hepatitis B
hepatitis C

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases