A Randomized Trial Comparing Radiofrequency Ablation and Surgical Resection for HCC Conforming to the Milan Criteria

OBJECTIVE: To compare the long-term outcomes of surgical resection and radiofrequency ablation for the treatment of small hepatocellular carcinoma (HCC). SUMMARY BACKGROUND DATA: Radiofrequency ablation (RFA) is a promising, emerging therapy for small HCC. Whether it is as effective as surgical resection (RES) for long-term outcomes is still indefinite. METHODS: Two hundred thirty HCC patients who met the Milan criteria and were suitable to be treated by either RES or RFA entered into a randomized controlled trial. The patients were regularly followed up after treatment for 5 years (except for those who died). The primary end point was overall survival; the secondary end points were recurrence-free survival, overall recurrence, and early-stage recurrence. RESULTS: The 1-, 2-, 3-, 4- and 5-year overall survival rates for the RFA group and the RES group were 86.96%, 76.52%, 69.57%, 66.09%, 54.78% and 98.26%, 96.52%, 92.17%, 82.60%, 75.65%, respectively. The corresponding recurrence-free survival rates for the 2 groups were 81.74%, 59.13%, 46.08%, 33.91%, 28.69% and 85.22%, 73.92%, 60.87%, 54.78%, 51.30%, respectively. Overall survival and recurrence-free survival were significantly lower in the RFA group than in the RES group (P = 0.001 and P = 0.017). The 1-, 2-, 3-, 4-, and 5-year overall recurrence rates were 16.52%, 38.26%, 49.57%, 59.13%, and 63.48% for the RFA group and 12.17%, 22.60%, 33.91%, 39.13%, and 41.74% for the RES group. The overall recurrence was higher in the RFA group than in the RES group (P = 0.024). CONCLUSIONS: Surgical resection may provide better survival and lower recurrence rates than RFA for patients with HCC to the Milan criteria.