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Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse (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 May 2011 by China Medical University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01311934
First Posted: March 10, 2011
Last Update Posted: May 26, 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
  Purpose

The acoustic radiation force impulse (ARFI) technology provides real-time measurements of tissue stiffness.

Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis scoring and to conduct subsequent innovative studies on liver diseases.


Condition
Visceral Stiffness Liver Fibrosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Application of the Spectrum of Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse Technology

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
HBV-infected
HCV-infected

Detailed Description:
Using ARFI technology, we are establishing a complete hepatic and visceral shear wave spectrum to correspond to the entire METAVIR fibrosis scoring and various functional stratifications.
  Eligibility

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
Patients with chronic liver diseases
Criteria

Inclusion Criteria:

  • patients with chronic liver diseases who underwent liver biopsy
  • patients with pathologically or radiologically proven cirrhosis

Exclusion Criteria:

  • Post major abdominal surgery
  • After interferon or neucleos(t)ides treatment
  • PBC,PSC,WD,AIH,viral coinfections
  • Liver abscess
  • Exposure to hepatotoxic drugs or chemicals
  • Thrombosis of splenic vein, portal veins
  • After resection or embolism of the spleen
  • Acute or chronic pancreatitis
  • Biopsy contraindications (not exclusive)
  • ARFI measurements low quality
  • Fibrotest contraindications:

Acute hepatitides, Extrahepatic cholestasis, e.g., pancreatic cancer, gallstones, CBD>0.7cm Severe hemolysis

  • Cardiac congestion
  • Liver cancer other than HCC
  • Treated HCC
  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): NCT01311934


Contacts
Contact: Sheng-Hung Chen, MD 886422052121 ext 2264 shcvghtc@gmail.com

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Sheng-Hung Chen, MD    886422052121 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: NCT01311934     History of Changes
Other Study ID Numbers: DMR100-IRB-001
First Submitted: March 7, 2011
First Posted: March 10, 2011
Last Update Posted: May 26, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases