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Clinical Trial
. 2022 Jan 10;12(1):316.
doi: 10.1038/s41598-021-03802-x.

Microwave versus radiofrequency ablation for the treatment of liver malignancies: a randomized controlled phase 2 trial

Affiliations
Clinical Trial

Microwave versus radiofrequency ablation for the treatment of liver malignancies: a randomized controlled phase 2 trial

Aleksandar Radosevic et al. Sci Rep. .

Abstract

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 as well as morphology of corresponding ablation zones. HCC and MT patients with 1.5-4 cm tumors, suitable for ablation, were randomized into MWA or RFA Groups. The primary endpoint was short-to-long diameter ratio of ablation zone (SLR). Primary technical success (TS) and a cumulative local tumor progression (LTP) after a median 2-year follow-up were compared. Between June 2015 and April 2020, 82 patients were randomly assigned (41 patients per group). For the per-protocol analysis, five patients were excluded. MWA created larger ablation zones than RFA (p = 0.036) although without differences in SLR (0.5 for both groups, p = 0.229). 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 MWA vs. RFA Group, respectively. Major complications were found in 5 cases (11%) vs. 2 cases (4%), without statistical significance. MWA and RFA show similar SLR, effectiveness and safety in liver tumors between 1.5 and 4 cm.

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Conflict of interest statement

A.R. and F.B. report non-financial support from HS Hospital Service (Rome, Italy). F.B. is inventor of a patent related with the applicator used in RFA Group (licensed to Apeiron Medical, Valencia, Spain). F.B. also reports personal lectures fees from HS Hospital service and personal lectures fees from Apeiron Medical. The other authors do not have any conflict of interest to disclose.

Figures

Figure 1
Figure 1
Clinical trial profile.
Figure 2
Figure 2
Kaplan–Meier curve of local tumor progression free survival (A) and overall survival (B) in HCC by group (MWA: microwave ablation; RFA: radiofrequency ablation).

References

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