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Keep this study
Lead
University of Pennsylvania
With
National Cancer Institute (NCI)
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
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Symptomatic portal hypertension secondary to cirrhosis undergoing elective outpatient TIPS
Age \>18, Age \<80
Capable of giving informed consent
You may not be if
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
Clareo Health | Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
