An interventional study of Linear EBUS first and Robotic-assisted bronchoscopy first in Pulmonary Nodules, sponsored by Northwestern University. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Northwestern University · Not applicable, Interventional, and Diagnostic
This study will randomize participants undergoing a bronchoscopic biopsy of a peripheral pulmonary nodule for their standard of care to receive robotic-assisted bronchoscopy (RaB) and then staging linear endobronchial ultrasounnd (EBUS) OR staging linear EBUS first, followed by RaB. The goal of this study is to set the standard for optimizing the sequence of bronchoscopic procedures in patients at risk for early-stage malignancy.
Robotic-assisted bronchoscopy (RaB) has afforded proceduralists the ability to accurately reach the periphery of the lung for biopsy of pulmonary nodules. This has paved the way for patients to undergo both biopsy of a peripheral nodule and a staging linear endobronchial ultrasound (EBUS) in the same anesthesia event, promoting quicker throughput from discovery of a lesion to guideline-adherent treatment. Further, introduction and mainstream utilization of cone-beam CT (CBCT) has provided the bronchoscopist the ability to refine needle position with tool-in-lesion confirmation. While there are no randomized clinical trials promoting efficacy of RaB and CBCT in comparison with other bronchoscopic methods, in single center retrospective studies, diagnostic yield has consistently proven to be in the 70-85% range, superior to prior technologies.
One of the limitations of utilization of RaB and CBCT is the detrimental effect that atelectasis plays in the bronchoscopy procedure. This can lead to false positive radial EBUS (rEBUS) signals and non-diagnostic procedures. This incidence of atelectasis has been evaluated prospectively, using a protocol featuring 8-10 cmH2O of PEEP and limiting hyperoxia, and results suggest this ventilator strategy does an adequate job preventing intraprocedural lung collapse. However, this study only evaluated incidence of atelectasis and did not elaborate on its impact on diagnostic yield.
Further unknown is the optimal sequence of performance of RaB and a staging linear EBUS in patients with a radiographically normal mediastinum. Starting with either the RaB or Linear EBUS both have their pros and cons. The benefit to performance of a linear EBUS first is the potential to obviate the need for peripheral nodule biopsy by obtaining rapid, on-site pathologic feedback of occult nodal disease, reducing some of the risk of the procedure (i.e. bleeding and pneumothorax). Conversely, the pitfalls to performing linear EBUS first is the possible contribution of atelectasis resultant of the increased time from intubation to peripheral nodule biopsy, blood in the airway causing bronchospasm, and resorption atelectasis from hyperoxia. There are no prospective data evaluating this in a randomized fashion, but one Monte Carlo simulation (with assumption of diagnostic yield from navigational bronchoscopy of 70% when performed first and 60% when performed second) suggested a higher diagnostic yield and less need for repeat procedure in the navigation first group, despite a 10% assumption of occult nodal disease.
As outlined in the specific aims above, the overarching goals of this study are to assess in a multicenter, randomized clinical trial performed by members of the Interventional Pulmonary Outcomes Group (IPOG), whether sequence of staging EBUS plays a role in diagnostic yield, incidence of atelectasis, and safety outcomes in patients undergoing RaB.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 320 is above the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Exclusion Criteria:
Patients will undergo a mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy
Diagnostic Test: Linear EBUS first
Patients will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second
Diagnostic Test: Robotic-assisted bronchoscopy first
Patients randomized to this arm will undergo a mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy.
Patients randomized to this arm will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second
Number of participants who received a diagnosis as a result of the procedure
This will be an outcome measure that is positive or negative based on whether a diagnosis was achieved during the procedure
Time frame: This will be assessed 30 days after the procedure in a study visit that our teams conduct, it will not include the patient
Severity of atelectasis during the procedure
Using the IPOG atelectasis score (mild, moderate, and severe) we will track the impact atelectasis has on the biopsy and diagnostic yield
Time frame: This will be assessed day of procedure and recorded
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be de-identified and collected in a secure REDCap database where only the lead site has access.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 10/28/24 - two years
Access criteria: Only study personnel.
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