Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis
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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 |
| 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 |
HBV or HCV-infected patients about to undergo liver biopsy to assist in clinical decision making
Inclusion Criteria:
- infected with HBV only or HCV only
Exclusion Criteria:
- concurrent HBV-HCV infection, etc.
Contacts and Locations| Contact: Sheng-Hung Chen, MD | 886-4-22052121 ext 2264 | shcvghtc@gmail.com |
| Taiwan | |
| China Medical University Hospital | Recruiting |
| Taichung, Taiwan, 40447 | |
| Contact: Sheng-Hung Chen, M.D. 886-4-22052121 ext 2264 shcvghtc@gmail.com | |
| 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 Pathologic Processes Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013