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Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02053571
First Posted: February 3, 2014
Last Update Posted: February 24, 2017
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.
Collaborator:
Siemens Medical Solutions
Information provided by (Responsible Party):
Robert A. Hieb, Medical College of Wisconsin
  Purpose

The goal of this study is to evaluate an alternate approach, which involves using a 3D puncture path overlay, to access the portal vein during a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The study should determine if the alternate approach provides these benefits: improved safety of procedure, and reduced intervention time (including reduction of radiation exposure), which benefits both interventional radiologist and the patient.

During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the vein above the collarbone in the neck) using fluoroscopy (x-ray) guidance. The shunt then is inserted between the portal vein (vein that carries blood from the digestive organs into the liver) to a hepatic vein (vein that carries blood away from the liver back to the heart).

In the standard approach, the interventional radiologist uses two-dimensional guidance (2D - having the dimensions of height and width only) to locate the path between the portal vein and hepatic vein. However, since these two veins do not connect, this method does not provide information on the three-dimensional (3D) relationship between the two veins.

In the alternate approach, the physician will have the option of using 3D guidance to locate the path. An on-table limited (small field of view) CT scan, used in combination with FDA approved imaging software, will provide a 3D image demonstrating the relationship between the portal vein and the hepatic vein. The 3D image is overlaid on the standard live x-ray images to assist in needle guidance during the TIPS procedure.

The CT scan performed will be in place of the angiograms that are typically performed. However, if the portal vein is not adequately seen in the CT images, the angiograms will be done and there will be no overlay. The procedure will proceed using the standard approach.


Condition Intervention
Portal Hypertension Procedure: TIPS with 3D Overlay

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure

Further study details as provided by Robert A. Hieb, Medical College of Wisconsin:

Primary Outcome Measures:
  • The number of cases in which the portal vein anatomy is accurately delineated in 3D using this technique [ Time Frame: At time of procedure ]

Secondary Outcome Measures:
  • x-ray dose [ Time Frame: At time of procedure ]
  • Procedure time [ Time Frame: At time of procedure ]

Enrollment: 20
Study Start Date: April 2014
Study Completion Date: August 4, 2016
Primary Completion Date: August 4, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TIPS with 3D overlay Procedure: TIPS with 3D Overlay

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prospective study of 20 patients, age 18 years or older, scheduled for clinically indicated TIPS procedure. Patients must be capable of providing informed consent.

Exclusion Criteria:

  • does not meet inclusion criteria.
  • portal vein does not opacify
  Contacts and Locations
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): NCT02053571


Locations
United States, Wisconsin
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Siemens Medical Solutions
Investigators
Principal Investigator: Robert A Hieb, MD Medical College of Wisconsin
  More Information

Responsible Party: Robert A. Hieb, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02053571     History of Changes
Other Study ID Numbers: PRO19417
First Submitted: January 24, 2014
First Posted: February 3, 2014
Last Update Posted: February 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension, Portal
Liver Diseases
Digestive System Diseases