Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04331184 |
| Other study ID # |
H-1907-157-1050 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 28, 2020 |
| Est. completion date |
December 30, 2022 |
Study information
| Verified date |
March 2021 |
| Source |
Seoul National University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, a dual / Twin Cooled-wet electrode was used to perform RFA therapy on residual
tumors after transarterial chemo-embolization and to find out the therapeutic results. The
primary endpoint is the 12-month local recurrence rate, and the secondary endpoint is the
survival rate, disease-free survival rate, actual procedure time, complications associated
with the procedure, and the technical success rate for securing a safety margin of 3 mm or
more around the tumor.
Description:
In the treatment of HCC, local interventional procedures such as transarterial
chemo-embolization and RFA are one of the most widely used methods. The probability of
complete necrosis is known to be about 50-60% and 80%, respectively, and in a few cases,
viable tumors remain, requiring additional treatment. Thus, in the treatment of residual
tumors after locoregional intervention, RFA therapy is known as a safe and effective
treatment, and in practice, it can be said to be a treatment that is often performed for the
treatment of residual viable tumors. Until now, single or alternating monopolar mode and
bipolar mode or multi-bipolar mode have been used for the transfer of radio frequency energy.
Unipolar mode is used most frequnetly. Currently, in the present application, an alternating
monopolar mode using three electrodes (Octopus electrode) and a bipolar mode using two
electrodes (Twin cooled wet electrod, RF Medical) have been mainly used. RFA therapy for
residual tumors after locoregional intervention has theoretically some limitations. First, it
is difficult to deliver a sufficient amount of the high-frequency electrode per hour due to
the high electrical resistance of the tissue due to tissue necrosis, fibrosis, and
distribution of non-homogeneous tissue after local intervention. Second, the high frequency
energy is distributed non-uniformly in the tissue. One of the ways to overcome this is to
generate a high heat in the center and periphery of the tumor to be treated, a method of
uniformly transmitting a large amount of energy such as high frequency or microwave, or a
strategy to improve the thermal conductivity and electrical conductivity. In order to do
this, saline is delivered to the high-frequency electrode to improve electrical conductivity,
and at the same time, high-frequency energy can be applied to the center of the tumor and the
periphery of the tumor if high-frequency energy can be transferred between the electrodes or
around the two electrodes installed in the tumor. It can be evenly delivered and the
efficiency of heat transfer is improved, which will improve the therapeutic effect of
high-frequency heat therapy on residual tumors after local intervention.
Recently, Rf Medical in Korea has developed a twin cooled wet (TCW) electrode capable of
injecting physiological saline into these high frequency electrodes and has been approved for
clinical use under medical insurance. About 30% has been used using a bipolar mode, which has
a theoretical advantage to concentrate high-frequency energy between the electrode and the
electrode. However, according to the experience in the present application, when the bipolar
mode is used, the rate of ablation is very fast and the transmission of high-frequency energy
is relatively easy in the center of the tumor, but the transmission of high-frequency energy
in the periphery of the tumor is relatively low, resulting in about 30% of tumors. A marginal
recurrence or residual tumor was experienced in the margin, and in the last 6 months, bipolar
mode and switching monopolar mode were combined to prevent recurrence in the periphery of the
tumor, and treatment was performed with the default setting. The result is low recurrence (6
months local recurrence rate of about 15%).
