Status:
TERMINATED
Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Portal Hypertension
Liver Fibroses
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation
Detailed 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 partici...
Eligibility Criteria
Inclusion
- Symptomatic portal hypertension secondary to cirrhosis undergoing elective outpatient TIPS
- Age \>18, Age \<80
- Capable of giving informed consent
Exclusion
- Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma
- Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion
- BMI \>35 and/or cirrhosis due to non-alcoholic steatohepatitis (due to inaccurate elastography measurements in patients with fatty liver)
- Urgent or emergent TIPS for bleeding
- Portal vein thrombosis with in the main, 1st, or 2nd order branches of the portal vein
- Hepatic vein thrombosis (ie no Budd Chiari syndrome)
- Excessive alcohol use defined as more than 2 oz in 24 hours on any individual day within the last 30 days
- Inability to provide informed consent
- Pregnant or nursing women
- Enrollment in concurrent therapeutic trial for symptomatic portal hypertension
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03352882
Start Date
August 1 2016
End Date
April 3 2019
Last Update
October 1 2019
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104