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Status unknownNCT04331184Updated Mar 17, 2021

RFA Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes

An interventional study of RFA using combined bipolar and monopolar energy deliver in Radiofrequency Ablation and Carcinoma, Hepatocellular, sponsored by Seoul National University Hospital. Status unknown at 1 site in South Korea. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed 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%).

02

Conditions studied

  • Radiofrequency Ablation
  • Carcinoma, Hepatocellular
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 102 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • agree to the protocol's requirements and submit a consent form
  • 20 years old-85 years old
  • Child-Pugh Class A and B
  • Patients with residual HCC after locoregional treatment who meet the following conditions A. Patients with a single nodular HCC within 5 cm or multiple nodular HCC of 3 or less in all cases of focal cancer B. Patients who did not have vascular invasion or extrahepatic metastasis during locoregional intervention

Exclusion criteria

Exclusion Criteria:

  • When the number of malignant HCC is 3 or more
  • If the tumor has a maximum size of 3 cm or more
  • diffuse infiltrative HCC
  • Child-Pugh class C
  • If there is an invasion of liver vessels due to malignant liver tumors
  • severe coagulopathy
  • multiple distant metastasis
  • situations where it is very unlikely to obtain appropriate data for research purposes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    RFA using combined bipolar and monopolar energy delivery

    Control group: The historic cohort is used to compare the results of the conventional alternating unipolar radiofrequency energy transfer mode with RFA.

    Procedure: RFA using combined bipolar and monopolar energy deliver

Interventions

  • ProcedureRFA using combined bipolar and monopolar energy deliver

    RFA technique combining bipolar mode and switching monopolar mode using dual / Twin Cooled-wet electrodes is performed on residual tumors after transarterial chemo-embolization.

06

What researchers measure

Primary outcomes

  1. Local tumor progression

    Time frame: 12 months

Secondary outcomes

  1. Overall survival rate

    Survival data

    Time frame: 12 months

  2. Recurrence free survival

    Survival data

    Time frame: 12 months

  3. Procedure time

    Procedure related outcome

    Time frame: immediately

  4. complication rate

    Procedure related outcome

    Time frame: immediately

  5. technical success rate

    Procedure related outcome

    Time frame: immediately

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, South Korea
    • SAE JIN PARK, MD · Contact · psjko05@gmail.com · 82220723107
    • Jeong Min Lee, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2020 (actual). Primary completion is estimated for Dec 2021, 23 months after the start.

Of 337 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 75. This study's planned 23 months is below that.

Counting every sponsor, half of 357 studies reached it within 48 months; a quarter within 23 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2020
First posted
Apr 2, 2020
StartActual
Jan 28, 2020
Primary completionEst.
Dec 30, 2021
CompletionEst.
Dec 30, 2022
Last update
Mar 17, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04331184
Responsible party
Jeong Min Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Apr 2, 2020
Start date
Jan 28, 2020
Primary completion
Dec 30, 2021 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Mar 17, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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