Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Using A Radiofrequency Guidewire

November 1, 2023 updated by: Khashayar Farsad, Oregon Health and Science University

Single-Arm, Single-Center, Pilot Study To Evaluate The Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation For Portal Hypertension Using A Radiofrequency Guidewire With Intravascular Ultrasound Guidance

A novel radiofrequency (RF) wire created by Baylis Medical (Montreal, CAN) is an FDA cleared device commonly used for percutaneous recanalization procedures. This wire has an active tip that delivers focused RF energy and has been applied for many procedures such as percutaneous transseptal left heart access, recanalization of central vein occlusion, recanalization of arterial occlusion, and recanalization of bile duct occlusion. There has been no study investigating the use of the RF wire for TIPS creation in clinical practice with humans. Having promising results of an experimental feasibility investigation in swine, the investigators are seeking to assess the feasibility and safety of the RF wire to cut through tissue in the liver while creating TIPS in the clinical setting.

Study Overview

Status

Completed

Conditions

Detailed Description

The transjugular intrahepatic portosystemic shunt procedure (TIPS), first described in 1969 by Rösch et al., has been widely used to treat the complications of portal hypertension such as recurrent variceal hemorrhage and refractory ascites.

In the TIPS procedure, an intrahepatic connection between a hepatic vein and a portal vein branch is created in order to reduce the portal venous pressure. A dedicated device developed for the TIPS procedure, the Rösch-Uchida Transjugular Liver Access Set (RUPS), is widely used for this procedure. The most challenging and time-consuming part of TIPS creation is puncturing the portal vein from the hepatic vein with a long needle trocar. Occasionally in cirrhotic livers, the trocar needle can deflect and not easily pass through the parenchyma. Needle deflection may lead to additional needle passes and potentially increase risk of inadvertent injury to the liver or extracapsular puncture. There is need, therefore, for a device that can easily penetrate dense liver tissue without creating significant trauma.

A novel radiofrequency (RF) wire created by Baylis Medical (Montreal, CAN) is an FDA cleared device commonly used for percutaneous recanalization procedures. This wire has an active tip that delivers focused RF energy and has been applied for many procedures such as percutaneous transseptal left heart access, recanalization of central vein occlusion, recanalization of arterial occlusion, and recanalization of bile duct occlusion.

The investigators have assessed the application of the RF wire for TIPS creation in a swine model. The investigators found that the use of this wire to cut through tissue during TIPS creation is feasible in swine with some potential advantages compared with the current available tools. The RF wire device was well visualized under intravascular ultrasound (IVUS) guidance and could penetrate through the liver parenchyma smoothly and safely. In addition, the RF wire was able to subsequently be used as a working wire to complete the procedure. Advantages in clinical practice with cirrhotic livers would be the relative ease of penetration into a hardened liver compared to the trocar needle, and the additional benefit of being able to use the device as a working wire to minimize the risk of catheter displacement and decrease procedure time.

There has been no study investigating the use of the RF wire for TIPS creation in clinical practice with humans. Having the promising results of the experimental investigation in swine, the investigators are seeking to assess the feasibility and safety of the RF wire to cut through tissue in the liver while creating TIPS in the clinical setting. It is anticipated that the proposed experimental technique using the RF wire would be at least as safe as the current standard technique. The wire diameter, 0.035 inches, is smaller than the traditionally used 0.038 inch needle trocar, and the deposition of RF energy is limited to the wire tip with minimal collateral damage. Risks of complications, such as puncturing unintended structures including the liver capsule, hepatic artery, gallbladder and biliary tree are anticipated to be at least as low as for the standard technique, estimated at about 3-4%. Moreover, these risks may be reduced even further in the experimental technique owing to the use of intravascular ultrasound guidance, enabling direct visualization of the puncture compared to the standard technique using landmarks and reference images under x-ray fluoroscopy.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with cirrhosis and portal hypertension meeting at least one indication for elective TIPS creation including refractory ascites, acute variceal bleeding not responsive to endoscopic treatment, prevention of recurrent variceal bleeding, portal hypertensive gastropathy, hepatorenal syndrome, Budd-Chiari syndrome, hepatic hydrothorax, hepatic veno-occlusive disease, and hepatopulmonary syndrome.
  2. Patients who agree to undergo TIPS procedure and participate in this clinical study.
  3. Age over 20 years

Exclusion Criteria:

  1. Patients with a contraindication for TIPS including congestive heart failure, severe tricuspid regurgitation, severe pulmonary hypertension, uncontrolled systemic infection or sepsis and unrelieved biliary obstruction.
  2. Patients in whom intravascular ultrasound cannot be used because of venous occlusion.
  3. Decisionally impaired patients
  4. Need for emergent TIPS creation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Undergo transjugular intrahepatic portosystemic shunt creation using a radiofrequency wire (Powerwire) in lieu of a trocar needle to cut through liver parenchyma
Using a radiofrequency wire in lieu of a needle for penetrating the liver during transjugular intrahepatic portosystemic shunt creation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of device-related adverse events (Safety)
Time Frame: within 24 hours
No device-related adverse events
within 24 hours
Feasibility to use the device as anticipated
Time Frame: within 24 hours
Ability of the device to perform as anticipated
within 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penetrating ability
Time Frame: within 24 hours
To assess the capability of the RF wire to cut through tissue without significant deflection through parenchyma
within 24 hours
Device use as a standard working wire
Time Frame: within 24 hours
To assess the capability of the RF wire to act as the working wire for delivery of the TIPS set into the portal vein after access.
within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Khashayar Farsad, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

January 29, 2019

Study Completion (Actual)

January 29, 2019

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OHSU eIRB # 16296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

HIPAA compliant, IRB-approved, non-identifiable information may be provided for research outcomes purposes.

IPD Sharing Time Frame

Anytime after study completion, per approved IRB protocol

IPD Sharing Access Criteria

IRB-approved protocols for access to data only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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