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

NCT02053571 | Completed

• 1 other identifier: PRO19417
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• The number of cases in which the portal vein anatomy is accurately delineated in 3D using this technique

  At time of procedure

Secondary Outcomes (2)

• x-ray dose

  At time of procedure

• Procedure time

  At time of procedure

Study Arms (1)

TIPS with 3D overlay

EXPERIMENTAL

Procedure: TIPS with 3D Overlay

Interventions

TIPS with 3D Overlay PROCEDURE

TIPS with 3D overlay

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• portal vein does not opacify

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Robert A Hieb, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: February 3, 2014
• Study Start: April 1, 2014
• Primary Completion: August 4, 2016
• Study Completion: August 4, 2016
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)