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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01283230
Enrollment
150
Registered
2011-01-25
Start date
2010-07-31
Completion date
2011-04-30
Last updated
2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease

Keywords

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

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.

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.

Interventions

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.

Sponsors

Severance Hospital
CollaboratorOTHER
Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of ARFI velocity in healthy donors and patients with chronic liver disease2 yearsMeasurement 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026