Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease|
- 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 ] [ Designated as safety issue: No ]Both measurements are estimates of portal hypertension (defined as equal to HVPG greater than 10 mmHg).
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: acoustic radiation force impulse (ARFI)
Imaging of liver and spleen using modified ultrasound
Device: ARFI ultrasound
ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures
Other Name: acoustic radiation force impulse
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644656
|Contact: Guadalupe Garcia-Tsao, MD||2039325711 ext 2207||Guadalupe.Garcia-Tsao@va.gov|
|United States, Connecticut|
|Yale-New Haven Hospital||Recruiting|
|New Haven, Connecticut, United States, 06511|
|Contact: Guadalupe Garcia-Tsao, MD firstname.lastname@example.org|
|VA Connecticut Healthcare System||Recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Guadalupe Garcia-Tsao 203-932-5711 ext 2206 email@example.com|
|Principal Investigator:||Guadalupe Garcia-Tsao, MD||VA Connecticut Healthcare System|