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

Not Applicable

Completed

• Conditions: Portal Hypertension; Chronic Liver Disease
• Interventions: Device: ARFI ultrasound

• Registration Number: NCT01644656
• Lead Sponsor: VA Connecticut Healthcare System

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.

Study Timeline

• Study First Submitted: 2012-06-19
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-19
• Status Verified: 2018-09
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acoustic radiation force impulse (ARFI)	ARFI ultrasound	Imaging of liver and spleen using modified ultrasound

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States