The SEQUENCE Trial: Evaluating Diagnostic Yield of Robotic-assisted Bronchoscopy When Staging EBUS is Performed First or Second in the Same Procedure

NCT ID: NCT06676956

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2027-04-01

Brief Summary

Robotic-assisted bronchoscopy (RaB) has afforded proceduralists the ability to accurately reach the periphery of the lung for biopsy of pulmonary nodules1. 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 treatment2. Further, introduction and mainstream utilization of cone-beam CT (CBCT) has provided the bronchoscopist the ability to refine needle position with tool-in-lesion confirmation3. 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 technologies4-6.

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 procedures7. This incidence of atelectasis has been evaluated prospectively, using a protocol featuring 8-10 cmH2O of PEEP and limiting hyperoxia8, 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).6 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 hyperoxia9. 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 disease10.

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.

Conditions

Pulmonary Nodules

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Linear EBUS First

Patients will undergo a mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy

Group Type: ACTIVE_COMPARATOR

Order of bronchoscopy procedures for peripheral nodule biopsy

Intervention Type: PROCEDURE

Patient scheduled to undergo peripheral nodule biopsy of the lung under bronchoscopy typically get both a nodule biopsy as well as a linear EBUS of the lymph nodes to assess for any disease spread. This procedure will randomize patients to either getting the peripheral nodule first or linear EBUS of the lymph nodes first and assess overall diagnostic yield as the primary outcome.

Robotic-assisted bronchoscopy first

Patients will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second

Group Type: ACTIVE_COMPARATOR

Order of bronchoscopy procedures for peripheral nodule biopsy

Intervention Type: PROCEDURE

Patient scheduled to undergo peripheral nodule biopsy of the lung under bronchoscopy typically get both a nodule biopsy as well as a linear EBUS of the lymph nodes to assess for any disease spread. This procedure will randomize patients to either getting the peripheral nodule first or linear EBUS of the lymph nodes first and assess overall diagnostic yield as the primary outcome.

Interventions

Order of bronchoscopy procedures for peripheral nodule biopsy

Patient scheduled to undergo peripheral nodule biopsy of the lung under bronchoscopy typically get both a nodule biopsy as well as a linear EBUS of the lymph nodes to assess for any disease spread. This procedure will randomize patients to either getting the peripheral nodule first or linear EBUS of the lymph nodes first and assess overall diagnostic yield as the primary outcome.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Kapp

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chris Kapp Assistant professor of medicine, MD

Role: CONTACT

christopher.kapp@nm.org

312-695-3800

Facility Contacts

Chris Kapp, MD

Role: primary

christopher.kapp@nm.org

312-695-3800

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00222248 (IRB)

Identifier Type: -

Identifier Source: org_study_id