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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02046473
Enrollment
18
Registered
2014-01-27
Start date
2013-07-31
Completion date
2015-04-30
Last updated
2016-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease, Portal Hypertension

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.

Interventions

PROCEDUREVolumetric 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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Estimate portal blood flow within a transjugular portosystemic shunt4 yearsTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026