ARTEMIS is a multicenter randomized controlled trial. The goal is to understand whether rapid onsite evaluation during robotic assisted bronchoscopy improves the diagnostic performance of the procedure or not.

Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. Robotic assisted bronchoscopy (RAB) with integrated cone beam computed tomography (CBCT) has achieved diagnostic yields exceeding 80% in some studies, significantly higher than traditional methods without advanced imaging, due to the added ability to correct alignment of the bronchoscopy catheter with the target lesion in real-time. Given this, the added value of rapid on-site cytologic evaluation (ROSE) with modern bronchoscopy is an area of debate. ROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy. This study will aim to test the hypothesis that modern bronchoscopy done without ROSE guidance is non-inferior to bronchoscopy with ROSE available. Patients undergoing RAB to biopsy a lung lesion will be approached for enrollment and assigned to either ROSE vs no ROSE if they agree to participate. Randomization will be revealed before procedures are started. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.

Inclusion Criteria:

• ≥ 18 years of age at time of bronchoscopy
• Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion

Exclusion Criteria:

• Declines to participate or inability to provide informed consent.
• Clinician determination that the use of ROSE is required or contraindicated for the optimal care of an individual patient
• Patient enrolled in another trial that requires ROSE for PPL biopsy
• Patient previously consented for this trial
• Pregnant or incarcerated patients

Individual participant data that underlie the results reported will be made available after de-identification.

The data will become available 3 months following publication of outcomes and will remain available for at least 3 years.

Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

It is not possible to blind the bronchoscopist given the nature of the intervention. However, patients and thoracic pathologists (outcome adjudicators) will remain blinded.