Back to results3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts
Primary Purpose
Portal Hypertension, Liver Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Volumetric Flow in TIPS
Sponsored by
About this trial
This is an interventional health services research trial for Portal Hypertension
Eligibility Criteria
Inclusion Criteria:
- Male and female 18 years of age and older
- Have an existing TIPS (Transjugular intrahepatic porto-systemic shunt)
- Have an ultrasound ordered by your physician to evaluate your TIPS.
- Able to read, understand and sign informed consent
Exclusion Criteria:
- Under 18 years of age
- Cannot be pregnant
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Volumetric Flow in TIPS
Arm Description
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.
Outcomes
Primary Outcome Measures
Estimate portal blood flow within a transjugular portosystemic shunt
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02046473
First Posted
January 23, 2014
Last Updated
November 9, 2016
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT02046473
Brief Title
3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts
Official Title
3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension, Liver Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volumetric Flow in TIPS
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Volumetric Flow in TIPS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Estimate portal blood flow within a transjugular portosystemic shunt
Description
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.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female 18 years of age and older
Have an existing TIPS (Transjugular intrahepatic porto-systemic shunt)
Have an ultrasound ordered by your physician to evaluate your TIPS.
Able to read, understand and sign informed consent
Exclusion Criteria:
Under 18 years of age
Cannot be pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Novelli, M.D.
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts
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