Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
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|ClinicalTrials.gov Identifier: NCT01644656|
Recruitment Status : Completed
First Posted : July 19, 2012
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Portal Hypertension Chronic Liver Disease||Device: ARFI ultrasound||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644656
|United States, Connecticut|
|Yale-New Haven Hospital|
|New Haven, Connecticut, United States, 06511|
|VA Connecticut Healthcare System|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Guadalupe Garcia-Tsao, MD||VA Connecticut Healthcare System|