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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01268865
First received: December 30, 2010
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

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
Liver Fibrosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Estimated Enrollment: 200
Study Start Date: December 2010
Groups/Cohorts
HBV-infected
HCV-infected

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sheng-Hung Chen, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01268865     History of Changes
Other Study ID Numbers: DMR99-IRB-240
Study First Received: December 30, 2010
Last Updated: June 2, 2011
Health Authority: Taiwan: Department of Health

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
Digestive System Diseases
Liver Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014