新型经支气管射频消融系统治疗肺部肿瘤的安全性和有效性:首次多中心大规模临床试验(BRONC-RFII)的一年随访。
Safety and efficacy of a novel transbronchial radiofrequency ablation system for lung tumours: One year follow-up from the first multi-centre large-scale clinical trial (BRONC-RFII).
发表日期:2024 Aug 28
作者:
Changhao Zhong, Enguo Chen, Zhuquan Su, Difei Chen, Feng Wang, Xiaoping Wang, Guangnan Liu, Xiaoju Zhang, Fengming Luo, Nan Zhang, Hongwu Wang, Longyu Jin, Fa Long, Chunfang Liu, Shiman Wu, Qing Geng, Xiang Wang, Chunli Tang, Ruchong Chen, Felix J F Herth, Jiayuan Sun, Shiyue Li
来源:
RESPIROLOGY
摘要:
射频消融(RFA)是一种新兴的肺癌治疗方法,但它存在一定的安全问题和操作限制。这是第一个多中心、大规模的临床试验,旨在研究创新型经支气管 RFA 系统治疗肺癌的技术性能、有效性和安全性。该研究纳入了使用自动盐水微灌注系统接受经支气管 RFA 的恶性肺肿瘤患者。 2021 年 1 月和 2021 年 12 月跨越 16 个医疗中心。主要终点是完全消融率。对该技术的性能和安全性以及 1 年生存率进行了评估。这项研究包括 126 名患者(年龄范围:23-85 岁),患有 130 个肺部肿瘤(平均大小:18.77 × 14.15 mm),他们接受了经支气管RFA 153次,技术成功率为99.35%,平均消融区域尺寸为32.47mm。 12个月随访时,完全消融率和肺内无进展生存率分别为90.48%和88.89%。磨玻璃结节(GGN)患者的结果优于实性结节患者(12个月完全消融率:实性 vs. 纯 GGN vs. 混合 GGN:82.14% vs. 100% vs. 96.08% ,p = 0.007)。没有报告设备缺陷。气胸、咯血、胸腔积液、肺部感染和胸膜疼痛等并发症发生率分别为3.97%、6.35%、8.73%、11.11%和10.32%。两名受试者在随访期间死亡。利用自动盐水微灌注系统的经支气管 RFA 是治疗肺部肿瘤的一种可行、安全和有效的方法,特别是对于 GGN 患者。© 2024 作者。约翰·威利出版的《呼吸学》
Radiofrequency ablation (RFA) is an emerging treatment of lung cancer, yet it is accompanied by certain safety concerns and operational limitations. This first multi-centre, large-scale clinical trial aimed to investigate the technical performance, efficacy and safety of an innovative transbronchial RFA system for lung tumours.The study enrolled patients with malignant lung tumours who underwent transbronchial RFA using an automatic saline microperfusion system between January 2021 and December 2021 across 16 medical centres. The primary endpoint was the complete ablation rate. The performance and safety of the technique, along with the 1-year survival rates, were evaluated.This study included 126 patients (age range: 23-85 years) with 130 lung tumours (mean size: 18.77 × 14.15 mm) who had undergone 153 transbronchial RFA sessions, with a technique success rate of 99.35% and an average ablation zone size of 32.47 mm. At the 12-month follow-up, the complete ablation rate and intrapulmonary progression-free survival rates were 90.48% and 88.89%, respectively. The results of patients with ground-glass nodules (GGNs) were superior to those of the patients with solid nodules (12-month complete ablation rates: solid vs. pure GGN vs. mixed GGN: 82.14% vs. 100% vs. 96.08%, p = 0.007). No device defects were reported. Complications such as pneumothorax, haemoptysis, pleural effusion, pulmonary infection and pleural pain were observed in 3.97%, 6.35%, 8.73%, 11.11% and 10.32% of patients, respectively. Two subjects died during the follow-up period.Transbronchial RFA utilizing an automatic saline microperfusion system is a viable, safe and efficacious approach for the treatment for lung tumours, particularly for patients with GGNs.© 2024 The Author(s). Respirology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Respirology.