The purpose of this study is to compare the therapeutic outcomes and safety of the study patients who received radiofrequency ablation (RFA) using separable clustered electrodes with those of a matched historical control group who had received RFA using multiple internally-cooled electrodes.
Although RFA is widely used as a curative treatment option for a variety of liver malignancies, it is generally limited for treating tumors larger than 2 cm in diameter with a sufficient tumor-free margin. Thus, various strategies are employed to create a sufficient ablation zone such as internally cooled-electrodes, expandable electrodes and adaptation of switching mono/bipolar controllers. Despite that these attempts have created larger ablative zones in clinical and preclinical studies, the efficacy should be validated in terms of clinical outcome. In this study, investigators evaluated the therapeutic outcomes and safety of RFA using separable clustered electrodes for treatment-naive hepatocellular carcinomas (HCCs) in comparison with RFA using multiple internally-cooled electrodes. The study group is a subgroup of our prospective study cohort (NCT02683538) and a control group is a matched historical group received RFA in our institution using multiple internally-cooled electrodes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
patients who signed informed consent, RFA was performed using separable clustered electrodes (Octopus®) in which, inter-tine distances can be flexibly adjusted by an operator.
Seoul National University Hospital
Seoul, South Korea
Cumulative 1-year local tumor progression (LTP) rate
Comparison of rates of LTP in two groups in a year after RFA
Time frame: 12 months after RFA
Cumulative 2-year LTP rate
Comparison of rates of LTP in two groups in two years after RFA
Time frame: 24 months after RFA
Cumulative 3-year LTP rate
Comparison of rates of LTP in two groups in three years after RFA
Time frame: 36 months after RFA
1-year Recurrence free survival rate
comparison of survival rate without disease progression in two groups
Time frame: 12 months after RFA
2-year Recurrence free survival rate
comparison of survival rate without disease progression in two groups
Time frame: 24 months after RFA
3-year Recurrence free survival rate
comparison of survival rate without disease progression in two groups
Time frame: 36 months after RFA
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