Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse

Liver Fibrosis Clinical Trial

— ARFI  

Official title:

Clinical Application of the Spectrum of Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01311934
• Other study ID #: DMR100-IRB-001
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2011
• Last updated: May 24, 2011
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2011
• Source: China Medical University Hospital
• Contact: Sheng-Hung Chen, MD
• Phone: 886422052121
• Email: shcvghtc[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Fibrosis
• Visceral Stiffness

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan,