The Journal of Thoracic and Cardiovascular Surgery
Thoracic: Lung CancerEndobronchial ultrasound-guided bipolar radiofrequency ablation for lung cancer: A first-in-human clinical trial
Graphical abstract
Section snippets
Study Design and Subjects
This single-center, prospective, unblinded, single-arm interventional study was approved by the institutional review board of the University Health Network (REB 17-5442, approved on September 11, 2017), and conducted at Toronto General Hospital (Toronto, Ontario, Canada) between April 2018 and October 2019. This study was registered at the ClinicalTrials.gov registry (NCT03400748). Health Canada approved the use of the RFA device for this study (number 268397). Written informed consent was
Patient Information
A total of 5 primary lung cancers were ablated in 5 separate patients (Figure E2). Information of these patients is summarized in Table 1. There were 3 men and 2 women (mean age, 73.8 ± 8.7 years). Three of the 5 patients presented with clinical stage II disease at diagnosis. Histologic diagnosis was adenocarcinoma in 4 patients and squamous cell carcinoma in 1 patient. CT images at each tumor's maximum axial diameter are shown in Figure 1, A. The mean tumor diameter was 4.4 ± 1.6 cm, with all
Discussion
This pilot study showed that EBUS-guided RFA can access lung tumors adjacent to airways, as well as monitor the deployment of the electrode and ablation in real-time without any immediate complications (Figure 4). Although the trial inclusion criteria did permit recruitment of patients with metastatic lesions, all ablated lesions were primary lung cancers.
There were no major immediate complications from the procedure. However, there was 1 mortality case on postoperative day 8 due to hemothorax.
Conclusions
This first-in-human ablate-and-resect trial showed that EBUS-guided bipolar RFA can access and ablate centrally located lung tumors using real-time ultrasound guidance. There were no major immediate complications, but 1 mortality event due to hemothorax occurred on postoperative day 8. Although specimen pathology suggested this event was unlikely to be related to the RFA itself, further assessment including long-term observation post RFA is needed to conclude its safety.
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Commentary: Ablation and endobronchial ultrasound for treating early lung cancer: Two great technologies that may work great together!
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Olympus Corporation financially supported this study, and provided the Active Needle Endoscopic Treatment devices.
The editorial review of this article was handled by Associate Editor Sudish C. Murthy, MD.