Radiofrequency AblationNCT04331184
RFA Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes
A study testing RFA using combined bipolar and monopolar energy deliver in people with Radiofrequency Ablation and Carcinoma, Hepatocellular, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Radiofrequency Ablation, Carcinoma, Hepatocellular
- What is being tested?
- RFA using combined bipolar and monopolar energy deliver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jan 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
SAE JIN PARK, MD, 82220723107, psjko05@gmail.com
Jeong Min Lee, MD, PhD
About this study
Official title: Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes: A Prospective Observational Study
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%).
- Conditions
- Radiofrequency Ablation, Carcinoma, Hepatocellular
- Being tested
- RFA using combined bipolar and monopolar energy deliver
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA using combined bipolar and monopolar energy deliverProcedure or surgery
RFA technique combining bipolar mode and switching monopolar mode using dual / Twin Cooled-wet electrodes is performed on residual tumors after transarterial chemo-embolization.
| Study group | Role | What they receive |
|---|---|---|
| RFA using combined bipolar and monopolar energy delivery | Experimental | Control group: The historic cohort is used to compare the results of the conventional alternating unipolar radiofrequency energy transfer mode with RFA. Receives: Procedure: RFA using combined bipolar and monopolar energy deliver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor progression
Measured: 12 months
Secondary outcomes (5)
Overall survival rate
Survival data
Measured: 12 months
Recurrence free survival
Survival data
Measured: 12 months
Procedure time
Procedure related outcome
Measured: immediately
complication rate
Procedure related outcome
Measured: immediately
technical success rate
Procedure related outcome
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start28 Jan 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiofrequency AblationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331184
- Sponsor's protocol ID
- H-1907-157-1050
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04331184
- Acronym / sponsor ID
- H-1907-157-1050
- Conditions
- Radiofrequency Ablation, Carcinoma, Hepatocellular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFA using combined bipolar and monopolar energy delivery | Experimental | Procedure: RFA using combined bipolar and monopolar energy deliverControl group: The historic cohort is used to compare the results of the conventional alternating unipolar radiofrequency energy transfer mode with RFA. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFA using combined bipolar and monopolar energy deliverRFA technique combining bipolar mode and switching monopolar mode using dual / Twin Cooled-wet electrodes is performed on residual tumors after transarterial chemo-embolization. | Procedure or surgery | RFA using combined bipolar and monopolar energy delivery |
Primary outcome
Local tumor progression
Time frame: 12 months
5 secondary outcomes
Overall survival rate
Time frame: 12 months
Recurrence free survival
Time frame: 12 months
Procedure time
Time frame: immediately
complication rate
Time frame: immediately
technical success rate
Time frame: immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA using combined bipolar and monopolar energy deliver in people with Radiofrequency Ablation and Carcinoma, Hepatocellular, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor progression (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.