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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046473
Recruitment Status : Completed
First Posted : January 27, 2014
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
Paula Novelli M.D., 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.

Condition or disease Intervention/treatment Phase
Portal Hypertension Liver Disease Procedure: Volumetric Flow in TIPS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts
Study Start Date : July 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046473


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Paula Novelli, M.D. University of Michigan Hospital

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Responsible Party: Paula Novelli M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02046473    
Other Study ID Numbers: HUM00054436
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Diseases
Hypertension, Portal
Digestive System Diseases