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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Siemens Medical Solutions
Information provided by (Responsible Party):
Robert A. Hieb, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT02053571
First received: January 24, 2014
Last updated: April 7, 2014
Last verified: April 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • x-ray dose [ Time Frame: At time of procedure ] [ Designated as safety issue: Yes ]
  • Procedure time [ Time Frame: At time of procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TIPS with 3D overlay Procedure: TIPS with 3D Overlay

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Robert A. Hieb, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02053571     History of Changes
Other Study ID Numbers: PRO19417
Study First Received: January 24, 2014
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 20, 2014