Clinical trial NCT03451149: Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Using A Radiofrequency Guidewire
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portal Hypertension
Keywords: TIPS
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Baylis Medical Company
First posted: 2018-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility to use the device as anticipated
timeFrame: within 24 hours
measure: Incidence of device-related adverse events (Safety)
timeFrame: within 24 hours
Secondary outcomes:
measure: Penetrating ability
timeFrame: within 24 hours
measure: Device use as a standard working wire
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Khashayar Farsad, MD
role: PRINCIPAL_INVESTIGATOR
References: