A multicenter randomized controlled trial of percutaneous cryoablation versus radiofrequency ablation in hepatocellular carcinoma.
Radiofrequency ablation (RFA) is considered a curative treatment option for hepatocellular carcinoma (HCC). Growing data have demonstrated that cryoablation represents a safe and effective alternative therapy for HCC, but no randomization controlled trial (RCT) has been reported to compare cryoablation with RFA in HCC treatment. The present study was a multicenter RCT aimed to compare the outcomes of percutaneous cryoablation with RFA for the treatment of HCC. Three hundred and sixty patients with Child-Pugh class A or B cirrhosis and one or two HCC lesions ? 4 cm, treatment naïve, without metastasis were randomly assigned to cryoablation (n=180) or RFA (n=180). The primary end-points were local tumor progression at 3 years after treatment, and safety. Local tumor progression rates at 1, 2, and 3 years were 3%, 7%, and 7% for cryoablation and 9%, 11%, and 11% for RFA, respectively (P=0.043). For lesions >3 cm in diameter, local tumor progression rate was significantly lower in cryoablation group versus RFA group (7.7% vs 18.2%, P=0.041). The 1-, 3-, and 5-year overall survival rates were 97%, 67% and 40%, for cryoablation and 97%, 66%, and 38% for RFA, respectively (P=0.747). The 1-, 3-, and 5-year tumor-free survival rates were 89%, 54%, and 35% in cryoablation group and 84%, 50%, and 34% in RFA group, respectively (P=0.628). Multivariate analyses demonstrated that Child-Pugh class B and distant intrahepatic recurrence were significant negative predictors to overall survival. Major complications occurred in seven patients (3.9%) following cryoablation and in six patients (3.3%) following RFA (P=0.776). Conclusion: Cryoablation resulted in a significantly lower local tumor progression, although both cryoablation and RFA were equally safe and effective with similar 5-year survival rates. (Hepatology 2014;).