https://orcid.org/0000-0001-8350-7584
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Abstract
Background
The novel separable clustered electrode system with two adjustable active tips (ICAEs) and a fine multipurpose needle (MPN) for in situ temperature monitoring and adjuvant agent injection was developed and validated in an animal study. The purpose of this study was to evaluate the technical efficacy and complication of the novel electrode system for patients who have small HCC.
Methods
In this prospective, single-center clinical trial, ten participants with 14 small (≤ 2 cm, BCLC 0-A) HCCs referred for RFA were enrolled. A novel electrode system consisting of two ICAEs and one MPN with a thermometer and side holes was used for RFA. The RF energy was delivered using a multichannel RF system combining bipolar and switching monopolar modes. Technical success, efficacy, and complications were evaluated on immediate and one-month follow-up CT.
Results
Technical success was achieved in 92.9% (13/14) of tumors. One participant withdrew consent after RFA, and technical efficacy was achieved in 91.7% (11/12) of tumors. None showed thermal injury to nontarget organs. All patients were discharged the day after RFA without major complications. The active electrode lengths were adjusted in 60% (6/10) of patients during the procedure to tailor the ablation zone (83.3%, n = 5) or treat two tumors with different sizes (16.7%, n = 1). MPN was capable of continuous temperature monitoring during all ablations (100%, 14/14).
Conclusions
RFA using a novel electrode system showed acceptable technical efficacy and safety in patients with small HCCs. Further comparative studies are needed for the investigation of the system’s potential benefits compared to conventional electrodes.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Data availability statement
The data that support the findings of this study are available on request from the corresponding author, Jeong Min Lee. The data are not publicly available due to the privacy of research participants.