Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study

PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020.

Abstract

Objective: This study aimed to compare the efficacy between bipolar radiofrequency ablation (RFA), using twin internally cooled wet (TICW) electrodes, and switching monopolar RFA, using separable clustered (SC) electrodes, in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.

Materials and methods: In this single-center, two-arm, parallel-group, randomized controlled study, we performed a 1:1 random allocation on eligible patients with recurrent HCC after locoregional treatment, to receive TICW-RFA or SC-RFA. The primary endpoint was the minimum diameter of the ablation zone per unit ablation time. Secondary endpoints included other technical parameters, complication rate, technical success and technique efficacy, and clinical outcomes.

Results: Enrolled patients were randomly assigned to the TICW-RFA group (n = 40) or SC-RFA group (n = 37). The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577). Total RF energy delivery (11.75 ± 9.04 kcal vs. 22.61 ± 12.98 kcal, p < 0.001) and energy delivery per unit time (0.81 ± 0.49 kcal/min vs. 1.45 ± 0.42 kcal/min, p < 0.001) of the TICW-RFA group were less than those of the SC-RFA group. No procedure-related death or major complications occurred. Technical success was achieved in all patients in both groups, and technique efficacy rates were 100% (46/46) in the TICW-RFA group and 95.0% (38/40) in the SC-RFA group (p = 0.213). The 1-year and 2-year cumulative LTP rates were 11.8% and 24.2%, respectively, in the TICW-RFA group, and 8.6% and 18.1%, respectively, in the SC-RFA group (p = 0.661).

Conclusion: In this single-center randomized controlled study from a Korean tertiary referral hospital, TICW-RFA demonstrated similar therapeutic efficacy and safety profile for recurrent HCC after locoregional treatment compared with SC-RFA.

Trial registration: ClinicalTrials.gov (NCT03806218).

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Carcinoma, Hepatocellular / pathology
  • Carcinoma, Hepatocellular / surgery*
  • Catheter Ablation / instrumentation
  • Catheter Ablation / methods*
  • Cold Temperature
  • Electrodes / classification*
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Humans
  • Liver Neoplasms / pathology
  • Liver Neoplasms / surgery*
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / surgery*
  • Prospective Studies
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT03806218

Grants and funding

J.M.L. received a research grant (grant number: 0620151800) from RF Medical Co., Ltd. (Seoul, Korea, http://www.rfa.co.kr). The funder had no role in study design, data collection, data analysis, decision to publish, or preparation of the manuscript.