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Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness

Portal Hypertension Clinical Trial

Official title:
Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness

Clinical Trial Summary

Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03352882
Study type Interventional
Source University of Pennsylvania
Contact
Status Terminated
Phase N/A
Start date August 2016
Completion date April 3, 2019
View Details
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