Shape-sensing Robotic-Assisted Bronchoscopy with cone beam CT for the investigation of pulmonary nodules: interim results of the first multicentre European trial

<bold>Introduction:</bold> Shape-Sensing Robotic-Assisted Bronchoscopy (ssRAB) is a novel alternative to traditional biopsy techniques for diagnosing pulmonary nodules. Intraprocedural three-dimensional imaging with cone beam CT (CBCT) may improve device precision. This is the first multicentre European study to evaluate the Ion Endoluminal system (Intuitive Surgical, CA) with CBCT. <bold>Aims:</bold> To investigate the effectiveness of combining ssRAB with cone beam CT (CBCT) in the biopsy of pulmonary nodules. <bold>Methods:</bold> A single arm, multicentre prospective study enrolling 200 subjects with pulmonary nodules sized between 6 to 30mm for biopsy using ssRAB with CBCT. The primary outcome is radiological tool-in-lesion. We report the interim outcomes for the first 100 subjects. NCT number: 05867953 <bold>Results:</bold> 108 nodules were sampled in 100 subjects (mean age 68 years, 71% female). The median size of nodules was 13mm (IQR 11-18mm), mean distance was 20mm from the pleura and 29% nodules had a positive bronchus sign. The rate of tool in lesion was 99% (88% in central third and 12% in outer two-thirds of nodule). Median procedure time was 48 minutes; median total radiation dose 12 Gy/cm2. 80 nodules were confirmed as malignant with sufficient tissue for molecular testing in 98% where it was requested. 28 nodules remain under surveillance. Five serious adverse events occurred in four subjects including one (1%) pneumothorax requiring chest drain insertion. In addition, two (non-serious) bleeding events required intervention (2%). <bold>Conclusion:</bold> ssRAB combined with CBCT enables the precise placement of sampling tools within 99% of target pulmonary nodules.