Multicenter Clinical Study of Transbronchial RFA in peripheral lung cancer: An interim analysis of 3-month Follow-up
Z. Changhaoa (Dr), S. Jiayuanb (Prof), C. Difeia (Mr), S. Zhuquana (Dr), C. Siguoc (Prof), W. Fengd (Prof), W. Xiaopinge (Prof), L. Guangnanf (Prof), Z. Xiaojug (Prof), L. Fengmingh (Prof), Z. Nani (Prof), W. Hongwuj (Prof), J. Longyuk (Prof), L. Fal (Prof), L. Chunfangm (Prof), W. Shimann (Prof), G. Qingo (Prof), W. Xiangp (Prof), T. Chunlia (Dr), L. Shiyue*a (Prof)
a The First Affiliated Hospital of Guangzhou Medical University, National Clinical Research Center for Respiratory, Guangzhou Institute of Respiratory Disease., Guangzhou, CHINA ; b Shanghai Chest Hospital, Shanghai, CHINA ; c Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, CHINA ; d Affiliated Beijing Chaoyang Hospital of Capital Medical University, Beijing, CHINA ; e Shandong Provincial Chest Hospital, Ji-Nan, CHINA ; f The Second Affiliated Hospital of Guangxi Medical University, Nanning, CHINA ; g Henan Province People Hospital, Zhengzhou, CHINA ; h West China Hospital of Sichuan University, Chengdu, CHINA ; i Emergency General Hospital, Beijing, CHINA ; j Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, CHINA ; k The Third Xiangya Hospital of Central South University, Changsha, CHINA ; l Shenzhen Hospital, University of Chinese Academy of Science, Shenzhen, CHINA ; m DaLian Municipal Central Hospital, Dalian, CHINA ; n The first hospital of Shanxi Medical University, Taiyuan, CHINA ; o Renmin Hospital of Wuhan University, Wuhan, CHINA ; p The Second Xiangya Hospital of Central South University, Changsha, CHINA
Background: Given the demonstrated good ablation effects of percutaneous radiofrequency ablation(RFA) and the hypothesis endobronchial approaches have a lower complication rates than transthoracic techniques, with the development of bronchoscopy navigation, transbronchial RFA was preliminary considered as an novel interventional treatment for inoperable lung cancer. But there is no comprehensive and systematic evidence to confirm its clinical efficacy and safety.
Method: This is a multicenter study of transbronchial RFA on peripheral lung tumor. A 3-month interim analysis of patients characteristic, RFA technique performance, and safety are described.
Result: Enrollment of 126 subjects from 16 clinical centers has completed 3-month follow-up, 54 subjects were female, and the median age was 67.5 (range:23-85). The mean tumour size(mean±SD) was 18.59mm±5.86 (range:5.22mm-29.58mm). COPD(16/126, 12.70%) and emphysema (8/126, 6.35%) represented the most predominant thoracic comorbidities. Bronchoscopic navigation was conducted in all procedure, with the assistance of fluoroscopy (86.51%, 109/126) , radical-EBUS (91.27%, 115/126), and other assist device. All the operations were uneventful with average ablation range of 31.34±11.45mm and median operative time of 81minutes. In terms of safety profiles, a total of 66 patients (66/126, 51.59%) had 194 adverse events according to 3-month follow-up. Incidence of hemoptysis was 6.35% (8/126), 7.94%(10/126) of pleural effusion, and 3.97%(5/126) of pneumothorax. 15 patients complained chest pain(15/126, 11.90%), and 5 patients had fever(5/126, 3.97%). 9 patients (9/126, 7.14%) developed with 13 serious adverse events in 3-month follow-up. All patients but one improved after systemic treatment. This patient dead due to pulmonary infection in 1 week after RFA procedure. Age >70 years and range of ablation were figured as independent risk factors for SAE by multivariate logistic regression analysis.
Conclusion: 3-month result of 126 subjects enrolled preliminary demonstrate satisfied technique performance and safety of transbronchial RFA procedure. Continued follow-up are required to further evaluate its efficacy and safety.
Disclosure of funding source(s): none