Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

NCT ID: NCT01283230

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Chronic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Acoustic radiation force impulse imaging

Intervention Type DEVICE

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.

Healthy liver and kidney donor

Healthy liver and kidney donor who have normal liver condition

Acoustic radiation force impulse imaging

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ARFI imaging

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role collaborator

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kwang-Hyub Han, MD

Role: STUDY_CHAIR

Department of Internal Medicine, Yonsei University College of Medicine

Seung Up Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Yonsei University College of Medicine

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1-2010-0015

Identifier Type: -

Identifier Source: org_study_id

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