Switching Monopolar Radiofrequency Ablation Using a Separable Cluster Electrode in Patients with Hepatocellular Carcinoma: A Prospective Study

Jin Woo Choi, Jeong Min Lee, Dong Ho Lee, Jeong-Hee Yoon, Kyung-Suk Suh, Jung-Hwan Yoon, Yoon Jun Kim, Jeong-Hoon Lee, Su Jong Yu, Joon Koo Han, Jin Woo Choi, Jeong Min Lee, Dong Ho Lee, Jeong-Hee Yoon, Kyung-Suk Suh, Jung-Hwan Yoon, Yoon Jun Kim, Jeong-Hoon Lee, Su Jong Yu, Joon Koo Han

Abstract

Objective: This study was conducted to evaluate the outcomes of multi-channel switching RFA using a separable cluster electrode in patients with HCC.

Methods: From November 2011 to July 2013, 79 patients with 98 HCCs < 5 cm were enrolled and treated with RFA using a multi-channel switching radiofrequency system and a separable cluster electrode under the guidance of a real-time fusion imaging system. The primary and secondary endpoints were the 3-year local tumor progression (LTP) rate and recurrence-free survival (RFS) rate, respectively. For post hoc analyses, LTP, RFS, and major complication rates were retrospectively compared with a historical control group treated with RFA using the same radiofrequency system but with multiple internally-cooled electrodes.

Results: The technique success rate of the 98 tumors was 100%. Cumulative 1-year, 2-year, and 3-year LTP rates were 3.4%, 6.9%, and 12.4%, respectively. For patient-level data, cumulative 1-year, 2-year, and 3-year RFS rates were 83.9%, 68.6%, and 45.4%, respectively. On post hoc analyses, none of the baseline characteristics showed a significant difference between the separable cluster electrode and multiple internally-cooled electrodes group. Cumulative LTP and RFS rates of the two groups also showed no significant difference (p = 0.401 and p = 0.881, respectively). Finally, major complication rates of the separable cluster electrode group (5.0%, 4/79) and multiple internally-cooled electrodes group (5.9%, 4/74) were also comparable (p = 1.000).

Conclusion: Switching monopolar RFA using a separable cluster electrode is a feasible and efficient technique for the treatment of HCCs smaller than 5 cm, providing comparable local tumor control to multiple internally-cooled electrodes.

Trial registration: ClinicalTrials.gov NCT02745483.

Conflict of interest statement

This project was funded by grant #1441 to J.M. Lee from STARmed corp (http://www.starmed4u.com). In addition, this does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Flowchart of the study population…
Fig 1. Flowchart of the study population enrollment.
Fig 2. Diagram of the “no-tumor-touch” technique…
Fig 2. Diagram of the “no-tumor-touch” technique to ablate a 1.5 cm sized HCC.
Fig 3
Fig 3
Photographs of a separable cluster electrode (Octopus®, STARmed) composed of three internally-cooled electrodes that can be incorporated as (A) one cluster electrode with a large shaft, or separated as (B) three individual applicators with small handles.
Fig 4. A representative case showing the…
Fig 4. A representative case showing the usefulness of a separable cluster electrode in ablating a large volume at one time.
(A) Axial CT image taken prior to RFA demonstrates a 3.4 cm sized, hypervascular lesion in the right lobe of the liver (arrowheads). (B) Intra-procedural US images fused with pre-procedural CT images guide the tumor (arrowheads) targeting and monitoring. (C) Axial CT image acquired immediately after RFA shows the ablation zone (arrowheads) sufficiently covering the index tumor, measured as 6.0 cm in long diameter, including the safety margin. (D) Coronal CT image reconstructed from the immediate post-procedural CT scan also depicts the ablation zone (arrowheads) measured as 5.9 cm in its coronal long axis.
Fig 5
Fig 5
Kaplan-Meier curves showing cumulative (A) local tumor progression and (B) recurrence-free survival rates after switching RFA of HCC, in the separable cluster electrode group and multiple internally-cooled electrode groups (p = .401 and p = .881, respectively).

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