Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Portal Hypertension
- Sponsor
- VA Connecticut Healthcare System
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)
Time Frame: 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).