BORIS - aBlação pOR mIcro-ondaS [Microwave Ablation]

Summary

Participation Requirements

Description

This study was designed to prospectively evaluate the safety and effectiveness of microwave ablation therapy in the treatment of metastatic lung lesions secondary to sarcoma. This technique has been proven to be successful in producing greater areas of ablation, increasing the chances of success and...

This study was designed to prospectively evaluate the safety and effectiveness of microwave ablation therapy in the treatment of metastatic lung lesions secondary to sarcoma. This technique has been proven to be successful in producing greater areas of ablation, increasing the chances of success and reducing the possibility of local recurrence, especially when compared to radiofrequency ablation. There will be 60 consecutive patients diagnosed and treated at the oncology clinic at the São Paulo State Cancer Institute that are going to participate in this study, after meeting the inclusion/ exclusion criteria. This number may be increased up to approximately about 20 patients, according to the sample behavior in the initial analysis and follow-up. All patients will be informed about the benefits, risks, complications and limitations related to the procedure and written informed consent will be applied. Patients will also be informed that microwave ablation is a new technology in Brazil, despite the extensive international experience and the results already validated in the medical literature. Logistic regression will be used to evaluate the success of the microwave ablation according to the characteristics of the lesion before the procedure. Logistic regressions for correlated data will be used to (a) evaluate the success of ablation according to all registered lesion characteristics, i.e., numeric characteristics (including tumor size and location) and categorical characteristics (histopathology of the primary tumor); (b) verify if combinations of two or more features of the lesions pose significant independent predictors for the success of ablation; and (c) construct a model to estimate the probability of success of the microwave ablation based on lesion characteristics before the procedure. The survival of patients will be assessed according to (a) the end result of the procedure (patients will be classified in two groups: an effective ablation group and a non-effective ablation group) and (b) the histopathological nature of the primary tumor. The survival rates will be calculated using the Kaplan-Meier test. The log-rank test (x² value of Cox-Mantel) will be used to determine statistically significant differences between the patients' survival rates. The value of P less than 0.05 will be considered to indicate a statistically significant difference for all analyses. Statistical software (Bias for Windows, version 8.4, Epsilon Verlag, Frankfurt, Germany) will be used.

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