Shape-sensing robotic-assisted bronchoscopy (ss-RAB) for peripheral pulmonary nodules: learning curve and diagnostic...

Shape-sensing robotic-assisted bronchoscopy (ssRAB) is an emerging technology in geographies outside the United States in use for complex pulmonary nodule biopsy. Geography specific data is needed to better understand outcomes in each population and health care system. The objective of this study is to assess the learning curve, diagnostic performance and safety of ssRAB in sampling peripheral pulmonary nodules (PPN) from an initial multicenter experience in China.

Consecutive patients with solid or part-solid nodules 8-30 mm in largest diameter were prospectively enrolled across three centers. Biopsy was performed using the ssRAB platform with 2D fluoroscopy and radial EBUS guidance only. Biopsy workflow was standardized across all centers. Subjects were followed through 30 days post-procedure. The primary endpoint was diagnostic yield per American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) definition. Secondary outcomes included procedure characteristics and incidence of procedure or device-related complications. Learning curve based on procedure time and diagnostic yield for each proceduralist was assessed using the cumulative sum method.

Ninety nodules from ninety subjects were biopsied with the ssRAB system. Average nodule size was (20.3 ± 4.9) mm. ATS/ACCP diagnostic yield was 90.0% (95% CI, 82.1%-94.7%). Multivariate analysis demonstrated no association with any nodule characteristic or imaging signal. Incidence of pneumothorax requiring chest tube was 1.1%. No severe airway bleeding was reported. Decreasing procedure time was observed through the case series with a suggested association to incremental procedure and bronchus sign presence. Two novice operators achieved diagnostic yield competency after 15 and 32 cases, respectively.

For PPN in China, ssRAB showed a strong diagnostic performance with high safety profile during first cases. Proficiency can be stably achieved among beginners at early stage of learning.

ClinicalTrials.gov (NCT06308120) 2024-04-03.