Clinical trial NCT02053571: Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
Official title: Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portal Hypertension
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2014-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: The number of cases in which the portal vein anatomy is accurately delineated in 3D using this technique
timeFrame: At time of procedure
Secondary outcomes:
measure: x-ray dose
timeFrame: At time of procedure
measure: Procedure time
timeFrame: At time of procedure
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Robert A Hieb, MD
role: PRINCIPAL_INVESTIGATOR
References: