肺部肿瘤的新型转换射频消融系统的安全性和有效性：首次多中心大规模临床试验（Bronc-RFII）进行的一年随访
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)
影响因子:6.30000
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
摘要
射频消融（RFA）是对肺癌的新兴治疗方法，但伴随着某些安全问题和操作局限性。这项第一次多中心大规模临床试验旨在研究用于肺部肿瘤创新的经桥式RFA系统的技术性能，功效和安全性。该研究招募了使用自动盐肿瘤的恶性肺肿瘤患者，他们使用自动盐水肿瘤使用自动盐盐RFA，使用自动盐盐Microperfusion系统在2021年1月2021年1月2021年1月2021年和12月2021日之间进行了16次Medical Centers。主要终点是完整的消融率。评估了该技术的性能和安全性，以及1年的存活率。这项研究包括126名患者（年龄范围：23-85岁），其中130个肺部肿瘤（平均大小：18.77×14.15 mm）接受了153次经支气管RFA会话的153次，具有99.35％的技术成功率，平均为99.35％和平均值。在12个月的随访中，完整的消融率和无肺内进展生存率分别为90.48％和88.89％。地面玻璃结节（GGN）患者的结果优于固体结节的患者（12个月的完整消融率：实心与纯GGN与混合GGN：82.14％vs. 100％vs. 96.08％，p = 0.007）。没有设备缺陷。在3.97％，6.35％，8.73％，11.11％和10.32％的患者中观察到诸如肺炎，止血，胸腔流体，肺部感染和胸膜疼痛之类的并发症。在随访期间，有两名受试者死亡。使用自动盐度微灌注系统的Transbronchial RFA是一种可用于肺肿瘤治疗的可行，安全有效的方法，特别是对于GGN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.