Protocol for robotic-assisted bronchoscopy versus electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules: a randomized trial (ARTICULAtE study)

摘要

Background: Electromagnetic navigation bronchoscopy (ENB) and shape-sensing robotic-assisted bronchoscopy (ssRAB) are the two dominant bronchoscopic technologies for the diagnosis of peripheral pulmonary nodules (PPNs). However, data directly comparing ENB and ssRAB are limited. We designed a randomized controlled trial to compare the diagnostic performance of these two technologies. The primary objective is to evaluate if ssRAB is superior to ENB for the diagnosis of PPNs. Methods: It is a multicenter, open-label, superiority randomized controlled trial. Patients with PPNs suspicious for lung cancer with a long-axis 8 to 30 mm are being approached for enrollment. The first 90 patients are being recruited as lead-in cases to allow the investigators to become familiar with the ssRAB system. A total of 264 patients will be enrolled in the randomized stage. The primary outcome is the diagnostic yield at the 6-month post-procedure follow-up. The secondary outcomes include diagnostic yield using a strict definition, diagnostic sensitivity of malignancies, the incidence of pneumothorax that requires chest tube placement and/or re-hospitalization or extended hospitalization within 1 month post-procedure, and the incidence of intraoperative severe airway bleeding. Enrollment for the study began in 20 March, 2024 and is currently in progress. Discussion: The results of this study will provide evidence to directly compare ssRAB and ENB in terms of diagnostic yield of PPNs and guide the selection of appropriate diagnostic techniques for different nodules. Trial Registration: ClinicalTrials.gov identifier: NCT06308120.