Carcinoma, HepatocellularNCT02832882
RFA for Small HCC With No-touch Technique Using Octopus Electrode
A study testing No-touch RFA and Conventional tumor puncture RFA in people with Carcinoma, Hepatocellular, run by Seoul National University Hospital.
Trial summary
In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- No-touch RFA and Conventional tumor puncture RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2016to 17 Jan 2020
- 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
- Child-Pugh class A
- patient with 1cm-2.5cm sized HCC
- 1 or 2 HCCs
- being referred for curative purpose of RFA
- sign informed consent
Who cannot join
- maximum tumor diameter greater than 2.5cm
- Child-Pugh class B or C
- more than 3 HCC lesions
- invisible tumor even after US/CT or US/MR fusion
- presence of vascular tumor thrombosis or extrahepatic metastasis
- severe coagulopathy (PLT < 50K, PT < 50% of normal range)
About this study
Official title: Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study
In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- No-touch RFA, Conventional tumor puncture RFA
- Keywords
- HCC, 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.
No-touch RFAProcedure or surgery
No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.
Conventional tumor puncture RFAProcedure or surgery
Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.
| Study group | Role | What they receive |
|---|---|---|
| No-touch RFA arm | Experimental | No-touch RFA arm indicates RFA procedure using Octopus electrode and no touch technique. Receives: Procedure: No-touch RFA |
| Conventional tumor puncture RFA arm | Active comparator | Conventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique. Receives: Procedure: Conventional tumor puncture RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 month local tumor progression (LTP) rate
Measured: 12 month after RFA
Secondary outcomes (3)
tumor seeding rate
incidence of tract seeding after RFA.
Measured: 12 months after RFA
Complication rate related with RFA
RFA-related complication rate such as death, abscess, bleeding..etc.
Measured: 1 month
Technical success rate
presence or absence of residual lesion on follow-up imaging
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start21 Oct 2016
- Primary completion11 Sep 2018
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 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
- NCT02832882
- Sponsor's protocol ID
- SNUH-2016-2244
- Status last verified
- Mar 2021
- First submitted
- 3 Jun 2016
- Last updated
- 22 Mar 2021
- 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 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study
- ClinicalTrials.gov ID
- NCT02832882
- Acronym / sponsor ID
- SNUH-2016-2244
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- HCC, RFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 14 Jul 2016 (estimated)
- 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, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-touch RFA arm | Experimental | Procedure: No-touch RFANo-touch RFA arm indicates RFA procedure using Octopus electrode and no touch technique. |
| Conventional tumor puncture RFA arm | Active comparator | Procedure: Conventional tumor puncture RFAConventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Child-Pugh class A
- patient with 1cm-2.5cm sized HCC
- 1 or 2 HCCs
- being referred for curative purpose of RFA
- sign informed consent
Key exclusion criteria (6 listed)
- maximum tumor diameter greater than 2.5cm
- Child-Pugh class B or C
- more than 3 HCC lesions
- invisible tumor even after US/CT or US/MR fusion
- presence of vascular tumor thrombosis or 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 |
|---|---|---|
| No-touch RFANo-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes. | Procedure or surgery | No-touch RFA arm |
| Conventional tumor puncture RFAConventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes. | Procedure or surgery | Conventional tumor puncture RFA arm |
Primary outcome
12 month local tumor progression (LTP) rate
Time frame: 12 month after RFA
3 secondary outcomes
tumor seeding rate
Time frame: 12 months after RFA
Complication rate related with RFA
Time frame: 1 month
Technical success rate
Time frame: 1 months
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 22 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.
Jeong Min Lee, MD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing No-touch RFA and Conventional tumor puncture RFA in people with Carcinoma, Hepatocellular, run by Seoul National University Hospital.
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 5 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 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
12 month local tumor progression (LTP) rate (time frame: 12 month 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 22 Mar 2021.