Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

Chronic Liver Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283230
• Other study ID #: 1-2010-0015
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: February 1, 2012
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: February 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of ARFI velocity in healthy donors and patients with chronic liver disease	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	2 years	No