Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

Yonsei University

Status: Completed

Conditions: Chronic Liver Disease

Treatments: Device: Acoustic radiation force impulse imaging

Study type: Observational

Funder types: Other

Identifiers

NCT01283230

1-2010-0015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

chronic liver disease

Description:

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.

Treatment:

Device: Acoustic radiation force impulse imaging

Healthy liver and kidney donor

Description:

Healthy liver and kidney donor who have normal liver condition

Treatment:

Device: Acoustic radiation force impulse imaging