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Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation
Single arm pilot study of adults ≥18yo investigating changes in liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Duration of participation is 30 days from TIPS creation. TIPS creation with Viatorr stent graft will be in accordance with its FDA-approved indication for symptomatic portal hypertension and per the manufacturer's instructions for use. Liver stiffness will be measured on pre-TIPS and post-TIPS ultrasounds using Phillips Epiq Ultrasound systems equipped with ElastPQ ultrasound shear wave elastography. Both ultrasounds will be performed at times which are standard of care before and after TIPS creation. Primary objectives include liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Secondary objectives include change in portosystemic gradient, clinical success as measured by difference in frequency of repeat paracentesis post-TIPS or freedom from recurrence of variceal bleeding and rate of hepatic encephalopathy. Exploratory objectives include serum biomarkers of liver stiffness.
Age
18 - 79 years
Sex
ALL
Healthy Volunteers
No
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
August 1, 2016
Primary Completion Date
April 3, 2019
Completion Date
April 3, 2019
Last Updated
October 1, 2019
1
ACTUAL participants
Ultrasound
DIAGNOSTIC_TEST
Lead Sponsor
University of Pennsylvania
Collaborators
Data Source & Attribution
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