Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

Completed

• Conditions: Chronic Liver Disease
• Interventions: Device: Acoustic radiation force impulse imaging

• Registration Number: NCT01283230
• Lead Sponsor: Yonsei University

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy liver and kidney donor	Acoustic radiation force impulse imaging	Healthy liver and kidney donor who have normal liver condition
chronic liver disease	Acoustic radiation force impulse imaging	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of