Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness

NCT03352882 | Terminated Results FDA Device

• 2 other identifiers: 826196U54CA193417
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Portal Hypertension; Liver Fibroses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PSG (mm hg) and ARFI (m/s) Correlation

  Pre-TIPS and 30 days Post-TIPS creation

• Frequency of Paracentesis and Recurrence of Variceal Bleeding

  30 days Post-TIPS and 12 months Post-TIPS creation

• Hyaluronic Acid and ARFI Correlation

  Pre-TIPS and 30 days Post-TIPS creation

• Tissue Inhibitor of Metalloproteinase-1 and ARFI Correlation

  Pre-TIPS and 30 days Post-TIPS creation

Study Arms (1)

Open Label

OTHER

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

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

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.

Open Label

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hypertension, Portal; Liver Cirrhosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Kimberly A. Forde, MD, PhD - Principal Investigator
• Organization: University of Pennsylvania

kforde@pennmedicine.upenn.edu

(215) 349-8222

Study Officials

• Kimberly Forde, MD, MHS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 24, 2017
• Study Start: August 1, 2016
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: October 1, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)