Assisted bronchoscopy for lung cancer management: comparison of a custom system to a historical cohort

The successful management of lung cancer patients requires timely and accurate disease diagnosis, through peripheral lesion analysis, and effective disease staging, through comprehensive central-chest lymph node staging. The state-of-the-art approach for performing follow-on diagnosis and staging procedures entails minimally invasive bronchoscopy. Because bronchoscopy is challenging, the medical device community has embarked on a massive ongoing effort to create assisted bronchoscopy systems. Unfortunately, current systems suffer from many drawbacks: they do not enable sufficiently accurate peripheral lesion diagnosis; they offer no guidance for nodal staging across both lungs; and they offer no guidance for supplemental devices typically needed during a procedure; they tend to subject a patient to significant radiation from supplemental imaging devices and demand long procedure times. As a step toward mitigating these drawbacks, we have devised two complementary turnkey subsystems for peripheral lesion analysis and central-chest lymph node staging, both of which had been previously tested in phantom, animal, and human feasibility studies. We now present a prospective patient study for the combined system for lung cancer diagnosis and staging within the context of the live clinical workflow. We also compare the results of this study to a historical controls patient cohort performed at our University’s medical center. Results indicate that our guidance system has the potential to enable far faster peripheral lesion bronchoscopies and nodal staging bronchoscopies, in comparison to the historical cohort. Also, the guidance system can potentially enable more efficient and accurate use of radial endobronchial ultrasound for peripheral lesions, without needing to resort to a radiation-intensive confirmational imaging modality, while also enabling the examination of substantially more nodal sites. With a mean joint procedure time under 10 minutes, the system could help realize more efficient and effective lung cancer diagnosis/staging bronchoscopies.