Safety and Utility of Endoscopic Ultrasound with Bronchoscope-guided Fine Needle Aspiration (EUS-B-FNA) in Suspected Lung Cancer Patients with Poor Respiratory or General Conditions: A Prospective Multicenter Observational Study

Abstract Background Although transbronchial diagnostic procedures are sometimes difficult to perform because of the patient’s respiratory or general conditions, endoscopic ultrasound with bronchoscope-guided fine-needle aspiration (EUS-B-FNA), a known transesophageal diagnostic procedure, might be useful for such cases. We conducted this prospective multicenter observational study to evaluate the safety and efficacy of EUS-B-FNA in suspected lung cancer patients with poor respiratory or general conditions Methods Suspected lung cancer patients with respiratory failure, Eastern Cooperative Oncology Group performance status of 2 or higher, or severe respiratory symptoms, were enrolled. The primary endpoints were the diagnostic yield of lung cancer and its safety, and the secondary endpoints were the success rate of molecular and programmed death ligand 1 (PD-L1) analyses, and 6-month survival rate in lung cancer patients. Results Thirty patients were enrolled, of which 29 were included in the analysis. Among them, 26 were finally diagnosed with lung cancer. The diagnostic yield for lung cancer was 100% (26/26). No adverse events were associated with EUS-B-FNA. The success rates of molecular analysis for EGFR, ALK, ROS-1, and BRAF were 100% (14/14), 100% (11/11), 100% (9/9), and 75% (6/8), respectively. The success rate of the PD-L1 analysis was 100% (15/15). The 6-month survival rate in lung cancer patients was 53.8% (95% CI: 33.4–76.4), and the median overall survival (OS) was 196 days (95% CI: 142–446). Conclusions EUS-B-FNA is a safe and effective diagnostic method, even in suspected lung cancer patients with poor respiratory or general conditions. Trial registration: This clinical trial was registered at https://www.umin.ac.jp/ctr/index.htm(UMIN000041235, approved on 28/07/2020).