Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03451149 |
| Other study ID # |
OHSU eIRB # 16296 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2017 |
| Est. completion date |
January 29, 2019 |
Study information
| Verified date |
November 2023 |
| Source |
Oregon Health and Science University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
