A Prospective Randomized Comparative Study of Three Guided Bronchoscopic Approaches for Investigating Pulmonary Nodules (The PRECISION-1 Study).
and Purpose: The capability of bronchoscopy in the diagnosis of peripheral pulmonary nodules (PPN) remains limited. Despite decades of effort, recent evidence suggests that the diagnostic accuracy for electromagnetic navigational bronchoscopy (EMN) and radial EBUS approach only 50%. New developments in robotic bronchoscopy (RB) may offer improvements in the assessment of PPN.and Methods: A prospective single blinded randomized controlled comparative study to assess success in localization and puncture of PPN utilizing an ultrathin bronchoscope with radial EBUS (UTB-rEBUS) vs EMN vs RB in a human cadaver model of PPN <2cm was performed. The primary endpoint was the ability to successfully localize and puncture the target nodule verified using cone-beam CT comparing RB and EMN. Secondary endpoints included needle to target position, “miss” distance and UTB-rEBUS comparisons.Sixty procedures were performed to target 20 PPN over the study period. Implanted PPN were distributed across all lobes, with 80% located within the lung periphery. Target PPN mean diameter was 16.5 ± 1.5mm with 50% noted to have a CT bronchus sign. The rate of successful PPN localization and puncture was superior using RB when compared to EMN (80% vs. 45%, p=0.02). Among unsuccessful needle passes, median needle to target “miss” distance was significantly different when comparing UTB-rEBUS, EMN and RB (p=0.0014).In a cadaver model, utilization of RB significantly increased the ability to localize and successfully puncture small PPN when compared with existing technologies. This study demonstrates the potential of RB to precisely reach, localize and puncture small nodules in the periphery of the lung.