一种新型经支气管射频消融系统治疗肺肿瘤的安全性与有效性：第一项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)

RESPIROLOGY

影响因子:6.3

分区:医学2区 / 呼吸系统2区

发表日期:2025 Jan

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

DOI: 10.1111/resp.14822

摘要

射频消融（RFA）是治疗肺癌的新兴方法，但伴随一定的安全性担忧和操作局限性。本研究首次多中心、大规模临床试验旨在评估一种创新的经支气管RFA系统在肺肿瘤治疗中的技术性能、疗效和安全性。研究在2021年1月至2021年12月期间，16家医疗中心招募接受自动盐微灌注系统治疗的恶性肺肿瘤患者。主要终点为完全消融率。评估该技术的操作性能、安全性及1年生存率。本研究共纳入126名患者（年龄范围：23-85岁），伴有130个肺肿瘤（平均尺寸：18.77×14.15 mm），共接受153次经支气管RFA，技术成功率为99.35%，平均消融区大小为32.47 mm。12个月随访显示，完全消融率为90.48%，肺内无进展生存率为88.89%。对结节类型的患者分析显示，结节为磨玻璃结节（GGN）的患者优于实性结节（12个月完全消融率：实性 vs. 纯G GN vs. 混合G GN：82.14% vs. 100% vs. 96.08%，p=0.007）。未报告任何设备缺陷。观察到的并发症包括气胸、咯血、胸腔积液、肺部感染和胸痛，发生率分别为3.97%、6.35%、8.73%、11.11%和10.32%。随访期间有两例患者死亡。利用自动盐微灌注系统的经支气管RFA是一种可行、安全且有效的肺肿瘤治疗方法，特别适用于G GN患者。

Abstract

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.