Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness

Not Applicable

Terminated

• Conditions: Liver Fibroses; Portal Hypertension
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT03352882
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-24
• Primary Completion: 2019-04-03
• Study Completion: 2019-04-03
• Results First Submitted: 2019-07-22
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-12
• Last Update Submitted: 2019-09-12
• Results First Posted: 2019-10-01
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	Ultrasound	All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS.

Primary Outcome Measures

Name	Time	Method
Decrease in Liver Stiffness	Pre-TIPS and 30 days Post-TIPS creation	The primary study endpoint will be decrease in liver stiffness following TIPS creation as measured by ARFI using mean propagation velocity values in meters per second. Mean normal values and mean values indicating severe fibrosis range about 0.8-1.7 m/s and about 1-3.4 m/s respectively. We hypothesize TIPS creation will reduce the liver stiffness by \> 50%. Change in liver stiffness will be correlated to change in PSG.

Secondary Outcome Measures

Name	Time	Method
Tissue Inhibitor of Metalloproteinase-1 and ARFI Correlation	Pre-TIPS and 30 days Post-TIPS creation	Correlation of tissue inhibitor of metalloproteinase-1, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness
PSG (mm hg) and ARFI (m/s) Correlation	Pre-TIPS and 30 days Post-TIPS creation	Baseline PSG (mm Hg) correlation to baseline liver stiffness by ultrasound ARFI (m/s)
Frequency of Paracentesis and Recurrence of Variceal Bleeding	30 days Post-TIPS and 12 months Post-TIPS creation	Difference in frequency of paracentesis and freedom from recurrence of variceal bleeding at 30 days and 12 months post-TIPS placement
Hyaluronic Acid and ARFI Correlation	Pre-TIPS and 30 days Post-TIPS creation	Correlation of hyaluronic acid, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States