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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Portal Hypertension, Chronic Liver Disease

Intervention / Treatment
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* Device: ARFI ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acoustic radiation force impulse (ARFI)<br>Imaging of liver and spleen using modified ultrasound | Device: ARFI ultrasound<br>* ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures<br>* Other names: acoustic radiation force impulse;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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portal hypertension, cirrhosis, ARFI, diagnostic study