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)
机构：[1]State Key Laboratory of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, National Clinical Research Center for Respiratory, GuangzhouInstitute of Respiratory Disease, Guangzhou, Guangdong, People’s Republic of China[2]Department of Respiratory and Critical Care Medicine, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Zhejiang, Hangzhou, People’s Republic of China[3]Department of Respiratory and Critical Care Medicine, Affiliated Beijing Chaoyang Hospital of Capital Medical University, Beijing, People’s Republic of China北京朝阳医院[4]Department of Respiratory and Critical Care Medicine, Shandong Provincial Chest Hospital, Jinan, Shandong, People’s Republic of China[5]Department of Respiratory and Critical Care Medicine, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People’s Republic of China[6]Department of Respiratory and Critical Care Medicine, Henan Province People Hospital, Zhengzhou, Henan, People’s Republic of China[7]Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, People’s Republic of China四川大学华西医院[8]Department of Respiratory and Critical Care Medicine, Emergency General Hospital, Beijing, People’s Republic of China[9]Department of Respiratory and Critical Care Medicine, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People’s Republic of China[10]Department of Respiratory and Critical Care Medicine, The Third Xiangya Hospital of Central South University, Changsha, Hunan, People’s Republic of China[11]Department of Respiratory and Critical Care Medicine, University of Chinese Academy of Sciences Shenzhen Hospital, Shenzhen, Guangdong, People’s Republic of China深圳市康宁医院深圳医学信息中心中国科学院大学深圳医院[12]Department of Respiratory and Critical Care Medicine, DaLian Municipal Central Hospital, Dalian, Liaoning, People’s Republic of China大连市中心医院[13]Department of Respiratory and Critical Care Medicine, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, People’s Republic of China[14]Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China[15]Department of Respiratory and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Changsha, Hunan, People’s Republic of China[16]Department of Pneumology and Critical Care Medicine, Thoraxklinik University of Heidelberg, Heidelberg, Germany[17]Department of Respiratory Endoscopy and Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai, People’s Republic of China
Background and Objective: 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. Methods: 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. Results: This study included 126 patients (age range: 23-85 years) with 130 lung tumours (mean size: 18.77 x 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. Conclusion: 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.
基金：
Guangdong special support plan project;
Guangzhou Science and Technology Plan Project,
Grant/Award Number: 202103010001
第一作者机构：[1]State Key Laboratory of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, National Clinical Research Center for Respiratory, GuangzhouInstitute of Respiratory Disease, Guangzhou, Guangdong, People’s Republic of China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Zhong Changhao,Chen Enguo,Su Zhuquan,et al.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)[J].RESPIROLOGY.2024,doi:10.1111/resp.14822.
APA：
Zhong, Changhao,Chen, Enguo,Su, Zhuquan,Chen, Difei,Wang, Feng...&Li, Shiyue.(2024).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,,
MLA：
Zhong, Changhao,et al."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 .(2024)
