Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04803890 |
| Other study ID # |
H-2003-068-1108 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
March 10, 2021 |
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
This study is a prospective multicenter study of the duration of treatment, the success rate,
the frequency of complications, and the local recurrence rate of 12 months when
Radio-frequency ablation therapy is performed for the treatment of HCC using the 'No touch'
technique as a combined high-frequency transmission mode with Octopus electrodes. It aims to
evaluate through. In addition, the results obtained from this prospective study were as
follows: 1) Patients who underwent Radio-frequency ablation therapy by puncturing an existing
tumor, and 2) Patients who underwent microwave ablation during the study period. The
secondary goal is to evaluate which method is more effective in reducing the treatment time
and recurrence rate compared to.
Description:
1. Pre-treatment planning:
The detailed plan of radio frequency ablation (RFA) will be implemented in accordance
with the routine procedure of image evaluation prior to RFA. That is, after confirming
the location of the tumor in the Multiphasic CT or MRI and evaluating the volume of the
tumor and the relationship with adjacent blood vessels before RFA procedure, planning
the insertion path and the number of ablation of the electrode for RFA, the recently
used US- The CT-MR fusion tool is used to fuse the pre-treatment image and the
ultrasound image to evaluate whether the tumor location on the ultrasound image matches
the tumor found on the pre-treatment image. The location will be evaluated in real time.
The end of the procedure is when an echo bubble of 5 mm to 10 mm or more is generated
around the treated tumor, and it is confirmed that the enhancement of HCC disappears
completely after RFA in immediate post procedure CT. In addition, if the boundary of the
tumor is not well drawn on ultrasound, CEUS will be additionally used to confirm the
location of the tumor. At this time, the ultrasonic fusion device to be used will be one
of Phillips, GE, Samsung or Siemens' navigation systems available herein. The fused
image guides the location of the electrodes to be installed in the tumor, the number of
electrodes, and a safe access route.
2. RFA procedure As a device for RFA, a multi-viva generator and a separable clustered
electrode (product name: Octopus electrode, Starmed Ltd), which are used herein, will be
used.
The procedure is to place the octopus high-frequency electrode in the periphery of the
tumor (5 ± 2mm) using no touch technique under fusion ultrasound guidance, and then
simultaneously apply high frequency to two electrodes up to 200W using the combined
monopolar-bipolar mode with keeping the temperature at 90-100 degrees Celsius for about
5 to 30 minutes until the tumor and 5-10 mm echo band form around the tumor. During the
RFA procedure, the US-CT-MR fusion tool (Navigator- GE & Siemens, Samsung) is used to
fuse the pre-treatment image and the ultrasound image to match the echo bubble
distribution and tumor location. It will be evaluated in real time.
If the boundary of the tumor is unclear, it is difficult to grasp the boundary of the
tumor 360 degrees as a whole, or if there is little normal tissue to install electrodes
around the tumor, it is difficult to apply the No-touch technique. Therefore, in this
study, the application rate of the No-touch technique will be evaluated among all
recruited patients, and when evaluating the presence or absence of recurrence after the
procedure, it is analyzed (intention to treat analysis) including puncture of the tumor,
and treated with actual No-touch. It will be analyzed further.
3. Follow-up
- CT (MRI if CT is contraindicated) will be performed immediately after RFA therapy
as previously performed as a clinical routine, and it will be evaluated whether
complete necrosis of the treated tumor has been achieved. If residual masses are
identified or insufficient safety margins are not secured, additional procedures
are performed and evaluated.
- Alternatively, AFP or CEA, CBC, LFT and CT or MRI are performed 1 to 3 months after
RFA procedure.
- The follow up method is the same as the existing method, and blood tests and CT or
MRI tests are performed every 3 to 4 months for 3 to 4 times during 12 months. This
is due to the fact that most local recurrence occurs within 12 months, and the
local recurrence rate will be evaluated based on this.
- The final point of time for this study is based on the follow-up findings obtained
at 12 ± 1 month after the procedure (short-term relapse rate evaluation).
- However, after that, the patient will continue to perform CT or MR follow-up every
3 to 6 months until 2 years according to the routine follow-up protocol of the
patient who has undergone existing RFA therapy.
4. Control group Of the patients who underwent RFA therapy for the treatment of HCC for a
period of 2 years from 2018 to 2020, the patient group had been treated with
conventional RFA and microwave ablation were enrolled. After performing the propensity
score matching analysis using variables of age, gender, tumor size, tumor location, and
liver function values, the same number of controls are selected and set.
