Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

NCT01283230 | Completed DMC

• 1 other identifier: 1-2010-0015
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease

Keywords

ARFI imaging; normal values; chronic liver disease; liver donors; kidney donors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Healthy liver and kidney donor

Healthy liver and kidney donor who have normal liver condition

Device: Acoustic radiation force impulse imaging

Interventions

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.

Also known as: ARFI imaging

Healthy liver and kidney donor; chronic liver disease

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic liver disease, Healthy liver and kidney donors

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead
• Severance Hospital: collaborator

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Elasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kwang-Hyub Han, MD

  Department of Internal Medicine, Yonsei University College of Medicine

  STUDY CHAIR

• Seung Up Kim, MD

  Department of Internal Medicine, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 25, 2011
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

KR (1)