Abstract
OBJECTIVE: Irreversible electroporation (IRE) is a nonthermal ablation technique for the treatment of malignant liver tumors. IRE has demonstrated efficacy and safety in the treatment of malignant liver tumors and its unique advantages in the treatment of nearby vascular lesions. This study aimed to compare the efficacy, safety, and intermediate-term outcomes of IRE and radiofrequency (RF) therapy in malignant liver tumors. METHODS: Twenty-four patients with primary or secondary liver malignancies were included in this prospective, double-arm clinical trial. Patients were randomly divided into the IRE and RF groups. The primary outcome was the efficacy (local ablation control evaluation at 90 days). The secondary outcomes were safety (procedure-related complications at ≤ 90 days) and intermediate-term survival (at 24 months). RESULTS: The ablation assessment at 90 days after surgery with mRECIST for IRE versus RF were 70%, 20%, 0%, and 10% versus 92.9%, 7.1%, 0%, and 0% (CR, PR, SD, and PD, respectively). The complication rates of IRE versus RF with Clavien-Dindo classification were 16.7%, 25%, 0%, 8.3%, and 8.3% versus 8.3%, 50%, 0%, 0%, and 0% (Grade I, II, III, IV, and V, respectively). The average overall survival (OS) was 17.55 months in the IRE group (95% CI 15.13-22.37) and 18.75 months in the RF group (95% CI 12.48-22.61). There was no statistical difference between the IRE and RF groups in terms of efficacy (p = 0.48), safety(p = 0.887), or 24-month OS (p = 0.959). CONCLUSIONS: IRE ablation revealed similar efficacy and safety in a short-term follow-up, and similar OS in mid-term survival as RF ablation in treating malignant hepatic tumors.