Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
Information provided by:
China Medical University Hospital Identifier:
First received: March 7, 2011
Last updated: May 24, 2011
Last verified: May 2011

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.

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)

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.

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

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
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 identifier: NCT01311934

Contact: Sheng-Hung Chen, MD 886422052121 ext 2264

China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Sheng-Hung Chen, MD    886422052121 ext 2264   
Sponsors and Collaborators
China Medical University Hospital
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 Identifier: NCT01311934     History of Changes
Other Study ID Numbers: DMR100-IRB-001
Study First Received: March 7, 2011
Last Updated: May 24, 2011

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases processed this record on April 28, 2017