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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
77
Bipolar RFA in which RF currents flow between two electrodes
Monopolar RFA using multiple electrodes with switching mode
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
Seoul National University Hospital
Seoul, South Korea
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.
Time frame: 3 days after RFA
Technique efficacy
Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
Time frame: 1 month after RFA
IDR rate
Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA
Time frame: 12 months, 24 months after RFA
EM rate
Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA
Time frame: 12 months, 24 months after RFA
Local tumor progression (LTP)
Cumulative LTP rates in two groups in 2 years after RFA
Time frame: 12 months, 24 months after RFA
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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.