NCT01644656

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: VA Connecticut Healthcare System · Federal
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Portal Hypertension
• Chronic Liver Disease

Interventions

Type	Name	Description
DEVICE	ARFI ultrasound	ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures

Timeline

• Start date: 2012-07-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2012-07-19
• Last updated: 2018-09-06

Locations

2 sites across 1 country: United States