Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

This study has been completed.

Sponsor:

Collaborator:

Severance Hospital

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01283230

First received: January 21, 2011

Last updated: February 1, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 21, 2011

Last Updated Date

February 1, 2012

Start Date ^ICMJE

July 2010

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of ARFI velocity in healthy donors and patients with chronic liver disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Measurement of ARFI velocity is non-invsive ultrasonographic technique. It is performed with a abdominal convex probe which is same probe as conventional ultrasonography. Short-duration acoustic radiation forces result in shear-wave propagation away from the region of excitation and are tracked using ultrasonic correlation-based methods. This results are called ARFI velocity which is expressed as meters per second

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01283230 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

Official Title ^ICMJE

Prospective Cohort Study for Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography in Patients With Chronic Liver Disease and Healthy Liver/Kidney Donors

Brief Summary

This is a prospective cohort Study for evaluation of liver fibrosis staging with acoustic radiation force impulse elastography in patients with chronic liver disease and healthy liver/kidney donors.

Detailed Description

A recent new method for liver fibrosis assessment based on similar technology to transient elastography is acoustic radiation force impulse (ARFI) imaging. ARFI has the advantages which can be conducted in parallel ways of measuring points in the patients with chronic liver disease when they underwent routine ultrasound examination. Thus, the aim of this study was to identify the normal range of ARFI velocity and assess the best cut-off value by recruiting healthy living liver and kidney donors.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with chronic liver disease, Healthy liver and kidney donors

Condition ^ICMJE

Chronic Liver Disease

Intervention ^ICMJE

Device: Acoustic radiation force impulse imaging

Acoustic radiation force impulse (ARFI) imaging were measured 10 times in each patient.The region of interest was chosen in an area where the normal liver parenchyma was at least 6 cm thick and free of large blood vessels was chosen. A measurement depth of 2 cm below the liver capsule was chosen to standardize the examination.

Other Name: ARFI imaging

Study Group/Cohort (s)

chronic liver disease
Any cause of liver disease that involves a process of progressive destruction and regeneration of the liver parenchyma leading to fibrosis and cirrhosis such as hepatitis B, hepatitis C, alcoholic liver disease.

Intervention: Device: Acoustic radiation force impulse imaging
Healthy liver and kidney donor
Healthy liver and kidney donor who have normal liver condition

Intervention: Device: Acoustic radiation force impulse imaging

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age > 20 years
chronic liver disease (hepatitis B, hepatitis C, liver cirrhosis) patients who are planned to liver biopsy
Healthy liver and kidney donors
The patients who is willing and able to provide written informed consent to participate in this study

Exclusion Criteria:

Decompensated liver cirrhosis
Patients with liver congestion due to heart dysfunction
Patients who previously take antiviral agent and antifibrotic agent
Healthy liver and kidney donors with any laboratory abnormalities regarding liver condition (Platelet count < 150 x 103/ul, Fasting glucose > 110 mg/dl, AST > 40 IU/L, ALT> 40 IU/L, Albumin < 3.3 g/dl, Total bilirubin > 1.2 mg/dl, GGT> 54 IU/L, ALP > 115 IU/L , Ferritin > 322 ng/ml)
A history of any other medical disease or condition that would make the patients unsuitable for this study

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01283230

Other Study ID Numbers ^ICMJE

1-2010-0015

Has Data Monitoring Committee

Yes

Responsible Party

Yonsei University

Study Sponsor ^ICMJE

Yonsei University

Collaborators ^ICMJE

Severance Hospital

Investigators ^ICMJE

Study Chair:	Kwang-Hyub Han, MD	Department of Internal Medicine, Yonsei University College of Medicine
Principal Investigator:	Seung Up Kim, MD	Department of Internal Medicine, Yonsei University College of Medicine

Information Provided By

Yonsei University

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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