Hepatocellular CarcinomaNCT03699657
Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC
A study testing DSM, SSM and Separable clustered 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 prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC). 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?
- DSM, SSM and Separable clustered electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2014to 19 Jun 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
- Diagnosed with HCC (>= 1.5cm and < 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
- no history of previous locoregional treatment
Who cannot join
- more than three HCC nodules
- tumors abutting to the central portal vein or hepatic vein with a diameter > 5 mm
- Child-Pugh class C
- tumors with major vascular invasion
- extrahepatic metastasis
- severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or INR prolongation of more than 50 %)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode
This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).
Read the detailed description
Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex vivo and in vivo animal experiments. A retrospective comparative study by Choi et al. reported that the DSM-RFA created significantly larger ablation volume than, but seemed to show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between DSM-RFA and the SSM-RFA would be helpful for improving results of RFA.
Therefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- DSM, SSM, 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.
DSMDevice
Monopolar RFA using dual switching mode (DSM)
SSMDevice
Monopolar RFA using single switching mode (SSM)
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 |
|---|---|---|
| RFA with DSM mode | Active comparator | RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. Receives: Device: DSM; Device: Separable clustered electrodes |
| RFA with SSM mode | Active comparator | RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. Receives: Device: SSM; Device: Separable clustered electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum diameter of ablative zone
Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.
Measured: 7 days after RFA
Secondary outcomes (5)
Technical success rate
Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
Measured: 1 month
IDR rate
Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA
Measured: 24 months after RFA
EM rate
Cumulative extrahepatic metastasis (EM) rate over two years after RFA
Measured: 24 months after RFA
1-year local tumor progression (LTP)
Comparison of rates of LTP in two groups in a year after RFA
Measured: 12 months after RFA
2-year LTP
Comparison of rates of LTP in two groups in two years after RFA
Measured: 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 posted9 Oct 2018
- Study start15 Dec 2014
- Primary completion11 Apr 2018
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 86 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
- NCT03699657
- Sponsor's protocol ID
- SNUH-2014-0279
- Status last verified
- Mar 2020
- First submitted
- 5 Oct 2018
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode
- ClinicalTrials.gov ID
- NCT03699657
- Acronym / sponsor ID
- SNUH-2014-0279
- Conditions
- Hepatocellular Carcinoma
- Keywords
- RFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 9 Oct 2018 (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 prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).
Detailed description
Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex vivo and in vivo animal experiments. A retrospective comparative study by Choi et al. reported that the DSM-RFA created significantly larger ablation volume than, but seemed to show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between DSM-RFA and the SSM-RFA would be helpful for improving results of RFA.
Therefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.
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 |
|---|---|---|
| RFA with DSM mode | Active comparator | Device: DSM, Device: Separable clustered electrodesRFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. |
| RFA with SSM mode | Active comparator | Device: SSM, Device: Separable clustered electrodesRFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with HCC (>= 1.5cm and < 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
- no history of previous locoregional treatment
Key exclusion criteria (6 listed)
- more than three HCC nodules
- tumors abutting to the central portal vein or hepatic vein with a diameter > 5 mm
- Child-Pugh class C
- tumors with major vascular invasion
- extrahepatic metastasis
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 |
|---|---|---|
| DSMMonopolar RFA using dual switching mode (DSM) | Device | RFA with DSM mode |
| SSMMonopolar RFA using single switching mode (SSM) | Device | RFA with SSM mode |
| 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 | RFA with DSM mode, RFA with SSM mode |
Primary outcome
Minimum diameter of ablative zone
Time frame: 7 days after RFA
Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.
5 secondary outcomes
Technical success rate
Time frame: 1 month
IDR rate
Time frame: 24 months after RFA
EM rate
Time frame: 24 months after RFA
1-year local tumor progression (LTP)
Time frame: 12 months after RFA
2-year LTP
Time frame: 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 20 Mar 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 DSM, SSM and Separable clustered 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 6 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 20 Mar 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 ablative zone (time frame: 7 days after RFA). 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 20 Mar 2020.