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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by China Medical University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01268865
First Posted: December 31, 2010
Last Update Posted: June 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
China Medical University Hospital
December 30, 2010
December 31, 2010
June 3, 2011
December 2010
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Complete list of historical versions of study NCT01268865 on ClinicalTrials.gov Archive Site
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Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis
Clinical Application of Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis in HBV and HCV-infected Patients
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
HBV or HCV-infected patients about to undergo liver biopsy to assist in clinical decision making
Liver Fibrosis
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  • HBV-infected
  • HCV-infected
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
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Inclusion Criteria:

  • infected with HBV only or HCV only

Exclusion Criteria:

  • concurrent HBV-HCV infection, etc.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01268865
DMR99-IRB-240
Yes
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Sheng-Hung Chen, China Medical University Hospital
China Medical University Hospital
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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
China Medical University Hospital
June 2011