Abstract
Purpose: Microwave (MWA) and radiofrequency ablation (RFA) are main ablative techniques for hepatocellular carcinoma (HCC) and colorectal liver metastasis (MT). This randomized phase 2 clinical trial compares the effectiveness of MWA and RFA in medium-sized liver tumors.Methods: HCC and MT patients with 1.5 to 4 cm tumors suitable for ablation were randomized into MWA or RFA Groups. The primary endpoints were primary technical success (TS) and local tumor progression (LTP) rate after a 2-year follow-up. Secondary endpoints were safety and overall survival. Results: Between June 2015 and April 2020, 82 patients were randomly assigned (41 patients per group). For the per-protocol analysis, three patients were excluded. Median follow-up was 27 months (MWA group) and 23 months (RFA Group). The TS was achieved in 98% (46/47) and 90 % (45/50) (p=0.108), and LTP was observed in 21% (10/47) vs. 12% (6/50) (OR 1.9 [95% CI 0.66-5.3], p=0.238) of tumors in the MWA and RFA Group, respectively. Major complications were found in 5 cases (11%) in the MWA Group vs. 2 cases (4%) in RFA, without statistical significance. MWA created larger ablation zones than RFA (p=0.036).Conclusion: MWA and RFA show similar effectiveness and safety in medium-sized liver tumors (1.5-4 cm).