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)
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...
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| Published in | Respirology (Carlton, Vic.) Vol. 30; no. 1; pp. 51 - 61 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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Chichester, UK
John Wiley & Sons, Ltd
01.01.2025
Wiley Subscription Services, Inc |
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| Abstract | 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 × 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.
The current prospective large‐scale, multi‐centre clinical trial has demonstrated transbronchial RFA with saline microperfusion as a safe and effective method for treating lung tumours.
See related editorial |
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| AbstractList | The current prospective large‐scale, multi‐centre clinical trial has demonstrated transbronchial RFA with saline microperfusion as a safe and effective method for treating lung tumours.
See related
editorial 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. 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.BACKGROUND AND OBJECTIVERadiofrequency 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.METHODSThe 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.RESULTSThis 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.CONCLUSIONTransbronchial 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. 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 × 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. The current prospective large‐scale, multi‐centre clinical trial has demonstrated transbronchial RFA with saline microperfusion as a safe and effective method for treating lung tumours. See related editorial Background and ObjectiveRadiofrequency 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.MethodsThe 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.ResultsThis 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.ConclusionTransbronchial 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. |
| Author | Zhong, Changhao Li, Shiyue Geng, Qing Zhang, Nan Jin, Longyu Chen, Enguo Long, Fa Su, Zhuquan Chen, Difei Wang, Feng Luo, Fengming Liu, Chunfang Chen, Ruchong Herth, Felix J. F. Wang, Xiang Wang, Hongwu Sun, Jiayuan Wu, Shiman Tang, Chunli Liu, Guangnan Wang, Xiaoping Zhang, Xiaoju |
| AuthorAffiliation | 11 Department of Respiratory and Critical Care Medicine University of Chinese Academy of Sciences Shenzhen Hospital Shenzhen Guangdong 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 16 Department of Pneumology and Critical Care Medicine Thoraxklinik University of Heidelberg Heidelberg Germany 7 Department of Respiratory and Critical Care Medicine West China Hospital of Sichuan University Chengdu Sichuan 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 4 Department of Respiratory and Critical Care Medicine Shandong Provincial Chest Hospital Jinan Shandong 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 13 Department of Resp |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/39197870$$D View this record in MEDLINE/PubMed |
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| Notes | editorial Changhao Zhong and Enguo Chen contributed equally to this study. See related ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Associate Editor: Daniel Steinfort; Senior Editor: Phan Nguyen See related editorial |
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| Snippet | Background and Objective
Radiofrequency ablation (RFA) is an emerging treatment of lung cancer, yet it is accompanied by certain safety concerns and... Radiofrequency ablation (RFA) is an emerging treatment of lung cancer, yet it is accompanied by certain safety concerns and operational limitations. This first... Background and ObjectiveRadiofrequency ablation (RFA) is an emerging treatment of lung cancer, yet it is accompanied by certain safety concerns and operational... The current prospective large‐scale, multi‐centre clinical trial has demonstrated transbronchial RFA with saline microperfusion as a safe and effective method... |
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| SubjectTerms | Ablation Adult Aged Aged, 80 and over bronchoscopy Bronchoscopy - instrumentation Bronchoscopy - methods Catheter Ablation - adverse effects Catheter Ablation - instrumentation Catheter Ablation - methods Clinical trials Female Follow-Up Studies ground‐glass nodule Humans Lung cancer Lung Neoplasms - mortality Lung Neoplasms - pathology Lung Neoplasms - surgery lung tumour Male Middle Aged Nodules Original ORIGINAL ARTICLE Patients Pleural effusion Pneumothorax Radiofrequency ablation Radiofrequency Ablation - adverse effects Radiofrequency Ablation - instrumentation Radiofrequency Ablation - methods Survival Survival Rate Treatment Outcome Tumors Young Adult |
| Title | 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) |
| URI | https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fresp.14822 https://www.ncbi.nlm.nih.gov/pubmed/39197870 https://www.proquest.com/docview/3150476942 https://www.proquest.com/docview/3099140965 https://pubmed.ncbi.nlm.nih.gov/PMC11688625 |
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