Robotic-assisted Bronchoscopy for Lung Nodules

(SEQUENCE Trial)

Overseen By Chris Kapp Assistant professor of medicine, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Enlarged lymph nodes, PET avid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

320 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Robotic-assisted Bronchoscopy for Lung Nodules?

Research shows that robotic-assisted bronchoscopy can improve the accuracy of lung nodule biopsies by providing better navigation and stability compared to older methods, which helps doctors get more reliable samples for diagnosis. ^{1 2 3 4 5}

Is robotic-assisted bronchoscopy safe for humans?

Robotic-assisted bronchoscopy is a new technology for lung nodule biopsies, and while it shows promise in accuracy, there are concerns about complications like significant airway bleeding, which require careful management. ^{1 2 3 4 5}

How is robotic-assisted bronchoscopy different from other treatments for lung nodules?

Robotic-assisted bronchoscopy is a new technology that improves the ability to accurately locate and biopsy lung nodules, especially those in hard-to-reach areas, compared to traditional methods. It offers higher diagnostic accuracy and safety, with a reported 96% success rate in identifying nodules, and helps overcome limitations of previous techniques like electromagnetic navigational bronchoscopy. ^{1 2 3 5 6}

Eligibility Criteria

This trial is for patients with small lung nodules needing a biopsy using robotic-assisted bronchoscopy. It's not open to those who already have enlarged or PET avid lymph nodes visible on CT scans before the procedure.

Inclusion Criteria

I am having a robotic-assisted bronchoscopy for a lung nodule.

Exclusion Criteria

My lymph nodes are enlarged or showed up on a PET scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo either a linear EBUS first followed by robotic-assisted bronchoscopy or vice versa, to evaluate diagnostic yield and safety outcomes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for diagnostic yield and atelectasis impact, assessed 30 days after the procedure

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Robotic-assisted Bronchoscopy

Trial Overview The study tests whether doing a staging EBUS (a type of ultrasound) before or after the robotic biopsy affects accuracy, occurrence of atelectasis (lung collapse), and safety in diagnosing lung nodules.

Participant Groups

Group I: Linear EBUS First Active Control 1 Intervention

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

Group II: Robotic-assisted bronchoscopy first Active Control 1 Intervention

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

Robotic-assisted Bronchoscopy is already approved in United States, European Union for the following indications:

Approved in United States as Robotic-assisted Bronchoscopy for:

• Diagnosis and staging of lung cancer
• Biopsy of pulmonary nodules

Approved in European Union as Robotic-assisted Bronchoscopy for:

• Diagnosis and staging of lung cancer
• Biopsy of pulmonary nodules

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

Robotic-assisted bronchoscopy offers a promising advancement for obtaining biopsies of peripheral pulmonary lesions, addressing the limitations of traditional bronchoscopic methods that often yield suboptimal results.

The review highlights the feasibility and sensitivity of various robotic-assisted platforms, suggesting they may improve diagnostic accuracy in lung biopsies compared to conventional techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Robotic-Assisted Bronchoscopy Platforms in the Sampling of Peripheral Pulmonary Lesions. Lu, M., Nath, S., Semaan, RW.[2021]

Robotic bronchoscopy improves the ability to navigate and biopsy peripheral pulmonary lesions compared to traditional methods, addressing issues like limited maneuverability and target confirmation.

While robotic bronchoscopy enhances tissue acquisition and reach in the airways, it currently lacks a high-fidelity system for confirming the biopsy target, indicating that further studies are needed to evaluate its effectiveness in diagnosing lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic bronchoscopy for peripheral pulmonary lesions: a convergence of technologies. Lin, J., Ost, DE.[2021]

Robotic-assisted bronchoscopy marks a significant advancement in bronchoscopic techniques, but there is a lack of documented strategies for managing severe airway bleeding in this context.

The case report outlines a novel approach using a combination of flexible and robotic bronchoscopy to effectively address complications related to airway bleeding, highlighting the need for further guidance in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Significant Airway Bleeding during Robotic Assisted Bronchoscopy: A Tailored Approach. Fernandez-Bussy, S., Abia-Trujillo, D., Majid, A., et al.[2021]

Robotic bronchoscopy (RB) demonstrated a diagnostic accuracy of 77% for lung lesions, with higher accuracy (85%) for lesions with concentric radial endobronchial ultrasound (r-EBUS) views, indicating its effectiveness in improving diagnostic outcomes.

The procedure had a low complication rate, with only 1.6% of patients experiencing pneumothorax and 3.2% reporting bleeding, while no cases of post-procedure respiratory failure were noted, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Diagnostic Accuracy of Robotic Bronchoscopy With 12-Month Follow-up. Agrawal, A., Ho, E., Chaddha, U., et al.[2023]

Robotic-assisted navigation bronchoscopy (RANB) has a high diagnostic yield of 81.9% for lung nodules, indicating it is an effective method for obtaining biopsies, based on a meta-analysis of 23 studies involving 1409 patients.

The complication rates associated with RANB are low, with pneumothorax occurring in only 0.60% of cases and major bleeding rates being less than 0.01%, suggesting that RANB is a safe option for lung nodule biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted Navigation Bronchoscopy: A Meta-Analysis of Diagnostic Yield and Complications. Pyarali, FF., Hakami-Majd, N., Sabbahi, W., et al.[2023]

In a study of 25 patients, robotic-assisted bronchoscopy achieved a high diagnostic yield of 96% for lung nodules, with no reported complications during the procedure.

The majority of the nodules evaluated were found to be malignant or atypical (76%), indicating that this method is not only safe but also effective in diagnosing potentially serious conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Nodule Evaluation Using Robotic-Assisted Bronchoscopy at a Veteran's Affairs Hospital. Ekeke, CN., Vercauteren, M., Istvaniczdravkovic, S., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of Robotic-Assisted Bronchoscopy Platforms in the Sampling of Peripheral Pulmonary Lesions. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Robotic bronchoscopy for peripheral pulmonary lesions: a convergence of technologies. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Management of Significant Airway Bleeding during Robotic Assisted Bronchoscopy: A Tailored Approach. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Factors Associated With Diagnostic Accuracy of Robotic Bronchoscopy With 12-Month Follow-up. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Robotic-assisted Navigation Bronchoscopy: A Meta-Analysis of Diagnostic Yield and Complications. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Lung Nodule Evaluation Using Robotic-Assisted Bronchoscopy at a Veteran's Affairs Hospital. [2021]