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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-09-30

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.

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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.

Conditions

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Portal Hypertension Chronic Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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acoustic radiation force impulse (ARFI)

Imaging of liver and spleen using modified ultrasound

Group Type EXPERIMENTAL

ARFI ultrasound

Intervention Type DEVICE

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

Interventions

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ARFI ultrasound

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

Intervention Type DEVICE

Other Intervention Names

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acoustic radiation force impulse

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No