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

NCT02046473 | Completed DMC

• 1 other identifier: HUM00054436
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension; Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Study Arms (1)

Volumetric Flow in TIPS

OTHER

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

Interventions

Volumetric Flow in TIPS PROCEDURE

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.

Volumetric Flow in TIPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 18 years of age
• Cannot be pregnant

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Hypertension, Portal; Liver Diseases

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Paula Novelli, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 10, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)