Abstract Rationale Pulsed electric field (PEF) ablation causing cell death through non-thermal mechanisms has been utilized in hepatocellular carcinoma, prostate cancer, and advanced lung cancer. There is currently limited published clinical evidence of PEF ablation in patients with early-stage non-small cell lung cancer (NSCLC) who are clinically judged surgical non-resectable or decline either surgical procedure or radiotherapy. While shape-sensing robotic-assisted bronchoscopy (ssRAB) has emerged as a critical tool for localizing or sampling peripheral pulmonary nodules, this study has advanced a step forward by aiming at evaluating the feasibility, safety and initial effectiveness of ssRAB-guided novel transbronchial PEF ablation in NSCLC. Methods The study is a single-arm prospective trial enrolling patients with early-stage (IA) NSCLC. Patients underwent transbronchial PEF ablation (Energenx Medical, Shanghai, China) with guidance of ssRAB (Intuitive Surgical, Sunnyvale, CA, USA) and mobile cone-beam CT (Siemens Healthineers, Erlangen, Germany). Treatment outcomes were evaluated based on follow-up chest CT. The primary endpoint was complete ablation rate at 6 months post-ablation, with secondary endpoints including procedural success rate, local tumor progression-free survival rate at 6 months post-ablation, overall survival (OS) and quality-of-life (QoL) scores through 12 months. Results As of the abstract submission, a total of 18 patients were enrolled with a total of 24 tumors undergoing 26 transbronchial PEF procedures via ssRAB. The first two patients underwent complementary PEF procedures per protocol. Seven patients had prior thoracic surgery. The mean lesion size was 11.1 ± 3.3mm, ranging from 8.2 to 22.3 mm. All lesions had pathological diagnosis prior to ablation, including 23 adenocarcinomas and 1 squamous cell carcinoma. The procedural success rate was 100% (26/26). No pneumothorax, hemorrhage or other procedural and/or device related severe adverse events (SAEs) were observed. Complete ablation at 3-month follow-up was achieved in 100% (10/10) of the patients. While more patients are being enrolled, all of them will be followed up through 12 months. Conclusion Early cases have demonstrated that novel transbronchial PEF therapy via ssRAB is a safe and feasible technique for patients with early-stage NSCLC. This abstract is funded by: This study was supported by Noncommunicable Chronic Diseases-National Science and Technology Major Project (2024ZD0522603) and Energenx Medical.
Sun et al. (Fri,) studied this question.