Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse (ARFI)

May 24, 2011 updated by: China Medical University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic liver diseases

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HBV-infected
HCV-infected

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

May 26, 2011

Last Update Submitted That Met QC Criteria

May 24, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMR100-IRB-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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