Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

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.

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Key information

Conditions

Chronic Liver Disease

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance Hospital

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acoustic radiation force impulse imaging

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.

Other names: ARFI imaging

Primary outcomes

Evaluation of ARFI velocity in healthy donors and patients with chronic liver disease

Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

Severance Hospital

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jan 25, 2011
Registry last updated: Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed