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

November 9, 2016 updated by: Paula Novelli M.D., University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Procedure: Volumetric Flow in TIPS
Subjects who have a TIPS (transjugular intrahepatic portal-systemic shunt) for portal hypertension will undergo a clinical 3D ultrasound to determine if the TIPS is working properly. Additional ultrasounds will be obtained during the subject's clinically ordered ultrasound(s). These measurements will be taken by using a second ultrasound probe (plastic hand held device that is rubbed along the subject's abdomen). 15 minutes will be added to your clinically ordered exams that are completed 4 times a year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate portal blood flow within a transjugular portosystemic shunt
Time Frame: 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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Paula Novelli, M.D., University of Michigan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00054436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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