Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Using A Radiofrequency Guidewire
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Radiofrequency wire (Powerwire)
Intervention type(s): Device
Intervention description(s): Using a radiofrequency wire in lieu of a needle for penetrating the liver during transjugular intrahepatic portosystemic shunt creation.
Intervention model: Single Group Assignment
Intervention model description: A single group of up to 10 participants will be enrolled to evaluate a radiofrequency wire for cutting through liver parenchyma instead of the standard trocar needle during transjugular intrahepatic portosystemic shunt creation. This will be to test this device for feasibility and not health outcomes.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: TIPS