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

VA Connecticut Healthcare System

Status: Completed

Conditions: Portal Hypertension; Chronic Liver Disease

Treatments: Device: ARFI ultrasound

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01644656

01582

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

acoustic radiation force impulse (ARFI)

Experimental group

Description:

Imaging of liver and spleen using modified ultrasound

Treatment:

Device: ARFI ultrasound