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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:9/8/2018
Start Date:July 2012
End Date:September 2018

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

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.

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.

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
We found this trial at
2
sites
950 Campbell Ave
West Haven, Connecticut 06516
(203) 932-5711
Phone: 203-932-5711
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
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West Haven, CT
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Haven, CT
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