Dataset Information

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

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.

SUBMITTER: Radosevic A

PROVIDER: S-EPMC8748896 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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

Radosevic Aleksandar A Quesada Rita R Serlavos Clara C Sánchez Juan J Zugazaga Ander A Sierra Ana A Coll Susana S Busto Marcos M Aguilar Guadalupe G Flores Daniel D Arce Javier J Maiques José María JM Garcia-Retortillo Montserrat M Carrion José Antonio JA Visa Laura L Villamonte María M Pueyo Eva E Berjano Enrique E Trujillo Macarena M Sánchez-Velázquez Patricia P Grande Luís L Burdio Fernando F

Scientific reports 20220110 1

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 ...[more]

PMID: 35013377

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Project description:IntroductionComplicated monochorionic twin pregnancies are often associated with high perinatal morbidity and mortality, some of which are severe enough to require a gestational reduction surgery to improve fetal survival and reduce disabilities. While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions. Currently there is limited evidence to prove the feasibility of MWA for selective reduction. The aim of this pilot study is to explore the feasibility, efficacy and safety of MWA reduction for severe complicated monochorionic pregnancies and may provide evidence for using the MWA in intrauterine surgeries extensively.Methods and analysisThis is a study protocol for a parallel-design pilot randomised controlled trial. 60 eligible patients with severe complicated monochorionic pregnancies will be randomised in a ratio of 1:1 to MWA group and radiofrequency group. Patients will be followed up until 6 months of age of the retained fetal. The primary analysis will compare the rates of neonatal survival at 28 days to evaluate the effect of MWA. The study will also evaluate the safety profile of MWA including the occurrence of postoperative adverse events and maternal and fetal complications. Additional secondary outcomes to be explored include the condition of neonatal asphyxia and the growth of surviving fetus at 6 months. Outcomes will be analysed by both a frequentist and the Bayesian statistical approach.Ethics and disseminationThis study was approved by the ethical review committee of the Peking University Third Hospital (Beijing, China). The results of this study will be published in peer-reviewed scientific journals and presented at relevant academic conferences.Trial registration numberNCT04014452; Pre-results.

Dataset Information

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

Publications

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

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