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 Details — Status: Terminated

Administrative data

• NCT number: NCT03352882
• Other study ID #: 826196
• Secondary ID: U54CA193417
• Status: Terminated
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 3, 2019

Study information

• Verified date: September 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 3, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Portal
• Liver Cirrhosis
• Liver Fibroses
• Portal Hypertension

Intervention

Diagnostic Test:
• Ultrasound
Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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