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

January 24, 2014
April 7, 2014
April 2014
February 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02053571 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Portal Hypertension
Procedure: TIPS with 3D Overlay
Experimental: TIPS with 3D overlay
Intervention: Procedure: TIPS with 3D Overlay
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
December 2018
February 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02053571
PRO19417
No
Robert A. Hieb, Medical College of Wisconsin
Medical College of Wisconsin
Siemens Medical Solutions
Principal Investigator: Robert A Hieb, MD Medical College of Wisconsin
Medical College of Wisconsin
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP