Image-Guided Radial-Probe EBUS Bronchoscopy System: Live Study Validation

Because radial-probe endobronchial ultrasound (RP-EBUS) can provide real-time confirmation of a suspect peripheral nodule situated outside of the airways, it is widely used during bronchoscopy for lung cancer diagnosis. RP-EBUS, however, tends to be difficult to use effectively, without some form of guidance. Previously, we had prototyped a multimodal image-guided bronchoscopy system that provides guidance during both bronchoscopic navigation and RP-EBUS localization. To use the system, the user first generates a guidance plan offline prior to the live procedure. Later, in the surgical suite, the user then employs the image-guided system to perform the desired multimodal RP-EBUS bronchoscopy, driven by the procedure plan. We now validate this system in a series of live studies. As the first set of end-to-end live system studies, we first tested the system in controlled animal studies. Through these studies, we tested the functionality and feasibility of the system prototype over the standard clinical workflow, without the usual risks associated with live patient procedures. Through these studies, we sharpened the workflow for the prototype and improved user interaction. We then tested the refined system over the standard clinical workflow in our University Hospital's lung cancer management clinic. This study proved the potential of our system for live clinical usage by demonstrating the safety, feasibility, and functionality of our complete system for guiding RP-EBUS bronchoscopy during peripheral nodule diagnosis.