Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography

This study has been completed.
Sponsor:
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01283230
First received: January 21, 2011
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Chronic Liver Disease
Device: Acoustic radiation force impulse imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Evaluation of ARFI velocity in healthy donors and patients with chronic liver disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Enrollment: 150
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: ARFI 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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic liver disease, Healthy liver and kidney donors

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283230

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01283230     History of Changes
Other Study ID Numbers: 1-2010-0015
Study First Received: January 21, 2011
Last Updated: February 1, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
ARFI imaging
normal values
chronic liver disease
liver donors
kidney donors

Additional relevant MeSH terms:
Fibrosis
Liver Diseases
Liver Cirrhosis
Pathologic Processes
Digestive System Diseases

ClinicalTrials.gov processed this record on July 20, 2014