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percutaneously, and one with an open procedure. There were 42 treatment-related adverse events and 11 serious adverse events totaling 53 adverse events in 40/246 (16.3%) patients. Of these adverse events, 11.3% (6/53) were Clavien-Dindo class III, with no class IV or V events. Only minimal change in renal function was noted in the 12-month period post treatment. The median estimated glomerular filtration rate decreased 3.85 mL/min with a median increase in creatinine of 0.06 mg/dL. The 36-month Kaplan-Meier estimate of time to recurrence, disease specific survival and overall survival for the RCC population was 94.8%, 100% and 91.9%, respectively.CONCLUSIONS: This rigorous, multicenter prospective study provides high-quality, reproducible evidence supporting the efficacy of cryoablation as a primary treatment for clinically suspicious renal masses.
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