Seoul National University Hospital
Seoul, South Korea
NCT Number: NCT02745483
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.
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Notify Me20 year and older
All sexes
Interventional
Phase 2
Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Octopus®
Time frame: 12 months after RFA
Comparison of rates of LTP in two groups in a year after RFA
Time frame: 24 months after RFA
Comparison of rates of LTP in two groups in two years after RFA
Time frame: 36 months after RFA
Comparison of rates of LTP in two groups in three years after RFA
Time frame: 12 months after RFA
comparison of survival rate without disease progression in two groups
Time frame: 24 months after RFA
comparison of survival rate without disease progression in two groups
Time frame: 36 months after RFA
comparison of survival rate without disease progression in two groups
Time frame: 30 days after RFA
Description and comparison of the type and incidence of major complication after RFA are assessed according to Society of Interventional Radiology (SIR) grading system in two groups.
Time frame: 1 day after RFA
comparison of rates of sufficient ablative zone creation which covers the whole tumor on post-RFA computed tomography (CT) in each group
Seoul National University Hospital
Other
Prospective, Single-center, Single-arm, Clinical Trial Evaluating the Clinical Efficacy and Safety of a Novel Separable Cluster Electrode in Patients With Focal Liver Malignancies
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