The SEQUENCE Trial (SEQUENCE)
The SEQUENCE Trial: Should Endobronchial Ultrasound QUeue bEfore or eNsuing to robotiC-assisted Bronchoscopy for pEripheral Pulmonary Nodule Biopsy?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chris Kapp Assistant professor of medicine, MD
- Phone Number: 312-695-3800
- Email: christopher.kapp@nm.org
Study Locations
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-
California
-
Sacramento, California, United States, 95817
- Recruiting
- University of California, Davis
-
Contact:
- Jeremy Kim
-
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Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
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Contact:
- Chris Kapp, MD
- Phone Number: 312-695-3800
- Email: christopher.kapp@nm.org
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Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University
-
Contact:
- Jeffrey Thiboutot
- Email: jthibou1@jhmi.edu
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Max Wayne
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North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Recruiting
- University of North Carolina, Chapel Hill
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Contact:
- Jason Akulian
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Peripheral Pulmonary Nodule undergoing a robotic-assisted bronchoscopy
Exclusion Criteria:
- lymph nodes that are enlarged or PET avid on CT prior to procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Linear EBUS First
Patients 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 mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy.
|
|
Active Comparator: Robotic-assisted bronchoscopy first
Patients will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second
|
Patients randomized to this arm will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants who received a diagnosis as a result of 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
|
This will be an outcome measure that is positive or negative based on whether a diagnosis was achieved during the procedure
|
This will be assessed 30 days after the procedure in a study visit that our teams conduct, it will not include the patient
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of atelectasis during the procedure
Time Frame: This will be assessed day of procedure and recorded
|
Using the IPOG atelectasis score (mild, moderate, and severe) we will track the impact atelectasis has on the biopsy and diagnostic yield
|
This will be assessed day of procedure and recorded
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00222248 (IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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