Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC
NCT ID: NCT03806218
Last Updated: 2020-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2015-05-16
2019-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TICW-RFA
Bipolar RFA using twin internally cooled-wet electrodes
Bipolar RFA
Bipolar RFA in which RF currents flow between two electrodes
Twin internally cooled-wet electrodes
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
SC-RFA
Switching monopolar RFA using separable clustered electrodes
SM-RFA
Monopolar RFA using multiple electrodes with switching mode
Separable clustered electrodes
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.
Interventions
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Bipolar RFA
Bipolar RFA in which RF currents flow between two electrodes
SM-RFA
Monopolar RFA using multiple electrodes with switching mode
Twin internally cooled-wet electrodes
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 electrodes
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCC nodules measuring 1 cm or larger and smaller than 5 cm
Exclusion Criteria
* 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 %)
20 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jeong Min Lee
Professor
Principal Investigators
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Jeong Min Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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SNUH-2015-0401
Identifier Type: -
Identifier Source: org_study_id
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