Clinical trial NCT03352882: Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
Official title: Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Portal Hypertension
Liver Fibroses
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-11-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: Inclusion Criteria:

* Symptomatic portal hypertension secondary to cirrhosis undergoing elective outpatient TIPS
* Age \>18, Age \<80
* Capable of giving informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Decrease in Liver Stiffness
timeFrame: Pre-TIPS and 30 days Post-TIPS creation
Secondary outcomes:
measure: PSG (mm hg) and ARFI (m/s) Correlation
timeFrame: Pre-TIPS and 30 days Post-TIPS creation
measure: Frequency of Paracentesis and Recurrence of Variceal Bleeding
timeFrame: 30 days Post-TIPS and 12 months Post-TIPS creation
measure: Hyaluronic Acid and ARFI Correlation
timeFrame: Pre-TIPS and 30 days Post-TIPS creation
measure: Tissue Inhibitor of Metalloproteinase-1 and ARFI Correlation
timeFrame: Pre-TIPS and 30 days Post-TIPS creation
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kimberly Forde, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: