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Background & Aim: Radiofrequency ablation (RFA) is an effective treatment for single hepatocellular carcinoma (HCC) 3cm. Disease recurrence is common, and in some patients will occur outside transplant criteria. We aimed to assess the incidence and risk factors for recurrence beyond Milan criteria (MC) in potentially transplantable patients treated with RFA as first-line therapy.Methods: We performed a retrospective cohort study of potentially transplantable patients with new diagnoses of unifocal HCC 3cm that underwent RFA as first-line therapy between 2000-2015. We defined potentially transplantable patients as those aged <70 years without any comorbidities that would preclude transplant surgery. Incidence of recurrence beyond MC was compared across two groups according to HCC diameter at the time of ablation: (HCC 2cm vs. HCC>2cm). Competing risks Cox regression was used to identify predictors of recurrence beyond MC. Results: We included 301 patients (167 134 HCC>2cm). Recurrence beyond MC respectively (p=0.01). The 1-, 3-and 5-years actuarial survival after RFA was 98.2%, 86.2% and (p=0.01). Tumor size >2cm [HR 1.94 (95%CI 1.25-3.02)] and alpha fetoprotein levels at the time of ablation [100-1000ng/mL: HR 2.05 (95%CI 1.10-3.83)] were found to be predictors of post-RFA recurrence outside MC. Conclusion: RFA for single HCC 3cm provides excellent short-to medium-term survival.However, we identified patients at higher risk of recurrence beyond MC. For these patients, liver transplantation should be considered right after the first HCC recurrence after RFA. HighlightsMost transplantable RFA will eventually develop recurrent HCC distant to the ablation site.Many transplantable patients treated with HCC will recur beyond the Milan criteria despite close post-RFA surveillance, losing the opportunity for cure.Transplantable patients with tumors >2cm and higher serum alpha fetoprotein have higher risk of recurrence beyond Milan criteria. Highlightswill eventually develop recurrent HCC distant to the ablation site.Many transplantable patients treated with HCC will recur beyond the Milan criteria despite close post-RFA surveillance, losing the opportunity for cure.Transplantable patients with tumors >2cm and higher serum alpha fetoprotein have higher risk of recurrence beyond Milan criteria.

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