Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)

Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01644656

Enrollment

500

Registered

2012-07-19

Start date

2012-07-31

Completion date

2018-09-30

Last updated

2018-09-06

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

Conditions

Chronic Liver Disease, Portal Hypertension

Keywords

portal hypertension, cirrhosis, ARFI, diagnostic study

Brief summary

The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.

Detailed description

DESIGN The study is designed as a prospective, cross-sectional, diagnostic study in which the investigators will evaluate the use of ARFI to diagnose clinically significant portal hypertension (CSPH defined as hepatic veous pressure gradient (HVPG)greater than 10 mmHg), taking HVPG measurements as gold standard. METHODOLOGY * The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale. * Study population will be recruited among patients from the VA/Yale Liver Clinics or outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.

Interventions

DEVICEARFI ultrasound

ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* age 18-85 years * compensated chronic liver disease with suspected or confirmed liver cirrhosis sent for transjugular liver biopsy as part of their routine care * signed informed consent

Exclusion criteria

* known contraindications to the performance of an HVPG measurement or a trans-jugular biopsy * portal thrombosis * previous surgical or transjugular portosystemic shunt * previous total or partial splenectomy * presence of comorbid conditions conferring a life expectancy of less than 1 year

Design outcomes

Primary

Measure	Time frame	Description
correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)	Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours	Both measurements are estimates of portal hypertension (defined as equal to HVPG greater than 10 mmHg).

Countries

United States

Outcome results

None listed

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