3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts

Not Applicable

Completed

• Conditions: Liver Disease; Portal Hypertension
• Interventions: Procedure: Volumetric Flow in TIPS

• Registration Number: NCT02046473
• Lead Sponsor: University of Michigan

Brief Summary

To determine if ultrasound measurements can accurately measure the blood pressure of flow across a stent that has been placed in a portal vein to reduce portal vein pressure known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.

Detailed Description

To determine if 3D ultrasound measurements can accurately measure the pressure of blood flow across a stent that has been placed in a portal vein. This has been done in order to reduce portal vein pressure. These shunts are known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Male and female 18 years of age and older
2. Have an existing TIPS (Transjugular intrahepatic porto-systemic shunt)
3. Have an ultrasound ordered by your physician to evaluate your TIPS.
4. Able to read, understand and sign informed consent

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Exclusion Criteria

1. Under 18 years of age
2. Cannot be pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volumetric Flow in TIPS	Volumetric Flow in TIPS	Subjects who have TIPS (transjugular intrahepatic porto-systemic shunts) have measurements taken to determine if someone has increased blood pressure in the portal vein of the liver (portal hypertension). Subjects who have a TIPS receive clinical ultrasounds every 3 months to determine if the TIPS is working properly.

Primary Outcome Measures

Name	Time	Method
Estimate portal blood flow within a transjugular portosystemic shunt	4 years	To determine the number of volumes to achieve a specified variance in the measurement and to determine the reproducibility of the volume flow measurements taken at multiple locations within the stent (3 locations with 3 measurements each for a total of 9 acquisitions).; The physicians will measure volume flow rate three times at three different locations in the shunt (that being proximal, medial and distal) to determine the reproducibility of the flow estimate.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States