Zhang Xiaobo, Zhang Xiao, Ding Xiaoyi, Wang Zhongmin, Fan Yong, Chen Guang, Hu Xiaokun, Zheng Jiasheng, Xue Zhixiao, He Xiaofeng, Zhang Xin, Wei Yingtian, Zhang Zhongliang, Li Jing, Li Jie, Yang Jie, Xue Xiaodong, Ma Li, Xiao Yueyong
Department of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.
Chinese PLA Medical School, Beijing, China.
Front Oncol. 2022 Sep 29;12:945123. doi: 10.3389/fonc.2022.945123. eCollection 2022.
Irreversible electroporation (IRE) is a soft tissue ablation technique that uses short electrical fields which induce the death of target cells. To evaluate the safety and efficacy of an IRE-based device compared to regular radiofrequency ablation (RFA) of solid liver tumors, in this multicenter, randomized, parallel-arm, non-inferiority study, 152 patients with malignant liver tumors were randomized into IRE (n = 78) and RFA (n = 74) groups. The primary endpoint was the success rate of tumor ablation; the secondary endpoints included the tumor ablation time, complications, tumor recurrence rates and treatment-related adverse events (TRAE). The success rate of tumor ablation using IRE was 94.9% and was non-inferior to the RFA group (96.0%) (P = 0.761). For the secondary endpoints, the average ablation time was 34.29 ± 30.38 min for the IRE group, which was significantly longer than for the RFA group (19.91 ± 16.08 min) (P < 0.001). The incidences of postoperative complications after 1 week (P = 1.000), 1 month (P = 0.610) and 3 months (P = 0.490) were not significantly different between the 2 groups. The recurrence rates of liver tumor at 1, 3 and 6 months after ablation were 0 (0.0%), 10 (13.9%) and 10 (13.3%) in the IRE group and 2.9%, 7.3% and 19.7% in the RFA control group (all P > 0.05), respectively. For safety assessments, 51 patients experienced 191 AEs (65.4%) in the IRE group, which was not different from the RFA group (73.0%, 54/184) (P = 0.646). In 7 IRE patients, 8 TRAEs (7.9%) occurred, the most common being edema of the limbs (mild grade) and fever (severe grade), while no TRAEs occurred in the RFA group. This study proved that the excellent safety and efficacy of IRE was non-inferior to the regular radiofrequency device in ablation performance for the treatment of solid liver tumors. : Chinese Clinical Trial Registry: ChiCTR1800017516.
不可逆电穿孔（IRE）是一种软组织消融技术，它利用短电场诱导靶细胞死亡。为了评估基于IRE的设备与实体肝肿瘤常规射频消融（RFA）相比的安全性和有效性，在这项多中心、随机、平行组、非劣效性研究中，152例恶性肝肿瘤患者被随机分为IRE组（n = 78）和RFA组（n = 74）。主要终点是肿瘤消融成功率；次要终点包括肿瘤消融时间、并发症、肿瘤复发率和治疗相关不良事件（TRAE）。IRE组肿瘤消融成功率为94.9%，不劣于RFA组（96.0%）（P = 0.761）。对于次要终点，IRE组平均消融时间为34.29±30.38分钟，显著长于RFA组（19.91±16.08分钟）（P < 0.001）。两组术后1周（P = 1.000）、1个月（P = 0.610）和3个月（P = 0.490）的并发症发生率无显著差异。IRE组消融后1、3和6个月的肝肿瘤复发率分别为0（0.0%）、10（13.9%）和10（13.3%），RFA对照组分别为2.9%、7.3%和19.7%（所有P > 0.05）。在安全性评估方面，IRE组51例患者发生191例不良事件（65.4%），与RFA组（73.0%，54/184）无差异（P = 0.646）。7例IRE患者发生8例TRAE（7.9%），最常见的是肢体水肿（轻度）和发热（重度），而RFA组未发生TRAE。本研究证明，IRE在实体肝肿瘤治疗的消融性能方面具有优异的安全性和有效性，不劣于常规射频设备。中国临床试验注册中心：ChiCTR1800017516。
