Hepatocellular CarcinomaNCT03806218
Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC
A study testing Bipolar RFA, SM-RFA and Twin internally cooled-wet electrodes in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Bipolar RFA, SM-RFA and Twin internally cooled-wet electrodes
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 May 2015to 12 Feb 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment
- HCC nodules measuring 1 cm or larger and smaller than 5 cm
Who cannot join
- more than three HCC nodules
- tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter > 5mm
- extrahepatic metastasis
- Child-Pugh class C
- severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study
This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Bipolar RFA, SM-RFA, Twin internally cooled-wet electrodes, Separable clustered electrodes
- Keywords
- RFA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar RFADevice
Bipolar RFA in which RF currents flow between two electrodes
SM-RFADevice
Monopolar RFA using multiple electrodes with switching mode
Twin internally cooled-wet electrodesDevice
Also called CWTN-T
Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity
Separable clustered electrodesDevice
Also called Octopus®
A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
| Study group | Role | What they receive |
|---|---|---|
| TICW-RFA | Active comparator | Bipolar RFA using twin internally cooled-wet electrodes Receives: Device: Bipolar RFA; Device: Twin internally cooled-wet electrodes |
| SC-RFA | Active comparator | Switching monopolar RFA using separable clustered electrodes Receives: Device: SM-RFA; Device: Separable clustered electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum diameter of ablation zone per unit time
Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.
Measured: 3 days after RFA
Secondary outcomes (4)
Technique efficacy
Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
Measured: 1 month after RFA
IDR rate
Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA
Measured: 12 months, 24 months after RFA
EM rate
Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA
Measured: 12 months, 24 months after RFA
Local tumor progression (LTP)
Cumulative LTP rates in two groups in 2 years after RFA
Measured: 12 months, 24 months after RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start16 May 2015
- Primary completion16 May 2018
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 77 participants (actual)
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
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806218
- Sponsor's protocol ID
- SNUH-2015-0401
- Status last verified
- Apr 2020
- First submitted
- 14 Jan 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Choi JW, Lee JM, Lee DH, Yoon JH, Kim YJ, Lee JH, Yu SJ, Cho EJ. Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study. PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020.
PubMed 32986758
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT03806218
- Acronym / sponsor ID
- SNUH-2015-0401
- Conditions
- Hepatocellular Carcinoma
- Keywords
- RFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 16 May 2015 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 16 Jan 2019 (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.
This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TICW-RFA | Active comparator | Device: Bipolar RFA, Device: Twin internally cooled-wet electrodesBipolar RFA using twin internally cooled-wet electrodes |
| SC-RFA | Active comparator | Device: SM-RFA, Device: Separable clustered electrodesSwitching monopolar RFA using separable clustered electrodes |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment
- HCC nodules measuring 1 cm or larger and smaller than 5 cm
Key exclusion criteria (5 listed)
- more than three HCC nodules
- tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter > 5mm
- extrahepatic metastasis
- Child-Pugh class C
- severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)
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 |
|---|---|---|
| Bipolar RFABipolar RFA in which RF currents flow between two electrodes | Device | TICW-RFA |
| SM-RFAMonopolar RFA using multiple electrodes with switching mode | Device | SC-RFA |
| Twin internally cooled-wet electrodesAlso: CWTN-TSaline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity | Device | TICW-RFA |
| Separable clustered electrodesAlso: Octopus®A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable. | Device | SC-RFA |
Primary outcome
Minimum diameter of ablation zone per unit time
Time frame: 3 days after RFA
Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.
4 secondary outcomes
Technique efficacy
Time frame: 1 month after RFA
IDR rate
Time frame: 12 months, 24 months after RFA
EM rate
Time frame: 12 months, 24 months after RFA
Local tumor progression (LTP)
Time frame: 12 months, 24 months after RFA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Derived from this study: PubMed 32986758Choi JW, Lee JM, Lee DH, Yoon JH, Kim YJ, Lee JH, Yu SJ, Cho EJ. Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study. PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020.
- 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.
Jeong Min Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar RFA, SM-RFA and Twin internally cooled-wet electrodes in people with Hepatocellular Carcinoma, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 7 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum diameter of ablation zone per unit time (time frame: 3 days after RFA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806218, which also lists 1 linked publication.
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 7 Apr 2020.