Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Liver Disease
• Intervention / Treatment: Device: Acoustic radiation force impulse imaging

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with chronic liver disease, Healthy liver and kidney donors

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: ARFI imaging
Healthy liver and kidney donor; Healthy liver and kidney donor who have normal liver condition	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.; Other Names: ARFI imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Severance Hospital
• Investigators: Study Chair: Kwang-Hyub Han, MD, Department of Internal Medicine, Yonsei University College of Medicine; Principal Investigator: Seung Up Kim, MD, Department of Internal Medicine, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): February 2, 2012
• Last Update Submitted That Met QC Criteria: February 1, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: chronic liver disease; ARFI imaging; normal values; liver donors; kidney donors
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Liver Cirrhosis
• Other Study ID Numbers: 1-2010-0015