title: Multicenter randomized controlled trial of percutaneous cryoablation versus radiofrequency ablation in hepatocellular carcinoma.
abstract: 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 randomized 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. In all, 360 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 endpoints 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, the local tumor progression rate was significantly lower in the cryoablation group versus the RFA group (7.7% versus 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 the cryoablation group and 84%, 50%, and 34% in the RFA group, respectively (P = 0.628). Multivariate analyses demonstrated that Child-Pugh class B and distant intrahepatic recurrence were significant negative predictors for overall survival. Major complications occurred in seven patients (3.9%) following cryoablation and in six patients (3.3%) following RFA (P = 0.776).
  
  
  CONCLUSIONS
  Cryoablation resulted in a significantly lower local tumor progression than RFA, although both cryoablation and RFA were equally safe and effective, with similar 5-year survival rates.
authors.affiliation: Center of Therapeutic Research for Hepatocellular Carcinoma, Beijing the 302nd Hospital, Beijing, China.
authors.forename: Chunping
authors.initials: C
authors.lastname: Wang
authors.forename: Huaming
authors.initials: H
authors.lastname: Wang
authors.forename: Wuwei
authors.initials: W
authors.lastname: Yang
authors.forename: Kaiwen
authors.initials: K
authors.lastname: Hu
authors.forename: Hui
authors.initials: H
authors.lastname: Xie
authors.forename: Ke-Qin
authors.initials: KQ
authors.lastname: Hu
authors.forename: Wenlin
authors.initials: W
authors.lastname: Bai
authors.forename: Zheng
authors.initials: Z
authors.lastname: Dong
authors.forename: Yinying
authors.initials: Y
authors.lastname: Lu
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zeng
authors.forename: Min
authors.initials: M
authors.lastname: Lou
authors.forename: Hong
authors.initials: H
authors.lastname: Wang
authors.forename: Xudong
authors.initials: X
authors.lastname: Gao
authors.forename: Xiujuan
authors.initials: X
authors.lastname: Chang
authors.forename: Linjing
authors.initials: L
authors.lastname: An
authors.forename: Jianhui
authors.initials: J
authors.lastname: Qu
authors.forename: Jin
authors.initials: J
authors.lastname: Li
authors.forename: Yongping
authors.initials: Y
authors.lastname: Yang
mesh_terms: D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D017115:Catheter Ablation; D003452:Cryosurgery / Q000379:methods; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015996:Survival Rate