Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath

Not Applicable

Completed

• Conditions: Peripheral Pulmonary Lesions; Lung Cancer
• Interventions: Procedure: Standard pEBUS with guide sheath; Procedure: Rapid on-site evaluation (ROSE); Procedure: Slim bronchoscope without a guide sheath

• Registration Number: NCT03809169
• Lead Sponsor: University of Calgary

Brief Summary

Peripheral pulmonary lesions (PPL) are defined as nodules or masses that are located in the lung periphery; hence cannot be seen via regular bronchoscopy. Due to their location, establishing a pathological diagnosis can be challenging. Investigations of PPL has significantly evolved in the last decade with the development of new technologies such as peripheral endobronchial ultrasound (pEBUS), virtual bronchoscopy and electromagnetic navigational bronchoscopy (ENB). Although these technologies have allowed physicians to safely biopsy previously difficult to access nodules, their sensitivity have been lower than trans-thoracic needle aspiration (TTNA). In fact, the largest registry to date has found a diagnostic yield of pEBUS of 57% compared to 93% for TTNA. However, TTNA caries substantially more procedural risk than pEBUS with a 25% rate of complication vs 2.8% for pEBUS (1, 2). With increased sensitivity, pEBUS could become the procedure of choice for PPL investigation in view of its safety profile. Rapid on-site evaluation of biopsy samples by a cytopathologist (ROSE) allows for direct evaluation of specimen adequacy. By offering real-time feedback to the bronchoscopist about specimen adequacy, the adding of ROSE to pEBUS could lead to an increase in diagnostic yield, allowing for a faster diagnosis of lung cancer and avoiding the need for further diagnostic procedures. Minitiazuration of broncoscopes can also allow navigation to more distal areas of the lung closer to the PPL. While this may also improve diagnostic yield, other technical modification such as the need for smaller sampling instruments and inability to use a guide sheath may have drawbacks.

This study will use a 2 x 2 factorial design to compare diagnostic yield of pEBUS bronchoscopic PPL sampling with vs. without ROSE as well as with a novel "slim" bronchoscope vs. standard bronchoscope. The investigators aim to randomize 208 patients to independently test each hypothesis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-18
• Study Start: 2019-11-01
• Primary Completion: 2024-03-30
• Study Completion: 2024-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

1. Adults ≥ 18 years old
2. Presence of a peripheral pulmonary lesion (PPL) of ≤5cm (mean short-long on axial CT) suspicious for malignancy.
3. The PPL appears radiologically accessible via pEBUS as assessed by an experienced interventional respirologist.
4. Absence of suspicious mediastinal lymphadenopathy on non-invasive staging defined as N1, N2 or N3 nodes ≥1cm on CT or ≥ moderate uptake on PET/CT unless shown to be negative on invasive sampling. Linear EBUS sampling of nodal stations will otherwise be permitted as part of a staging procedure.
5. Clinical decision made by patient and treating physician to proceed to bronchoscopy.

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Exclusion Criteria

1. Other intervention indicated as primary diagnostic procedure (eg: TTNA, surgical lung biopsy, linear EBUS alone, biopsy of extra-thoracic lesion)
2. Location of lesion not amenable to transbronchial needle aspiration sampling as assessed by an experienced interventional respirologist.
3. Contra-indication to pEBUS or bronchoscopy such as: severe pulmonary hypertension (mean pulmonary arterial pressure of ≥25mmHg with evidence of right heart failure), unstable medical condition or uncorrected coagulopathy.
4. Pregnancy
5. Use of electromagnetic or other navigation system (virtual bronchoscopic planning is allowed)
6. Absence of informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ROSE without guide sheath	Slim bronchoscope without a guide sheath	Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no guide sheath and the presence of ROSE.
Guide sheath without ROSE	Standard pEBUS with guide sheath	Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique but without ROSE.
No guide sheath without ROSE	Slim bronchoscope without a guide sheath	Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no the guide sheath an without the presence of ROSE.
ROSE with guide sheath	Rapid on-site evaluation (ROSE)	Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique and presence of ROSE
ROSE without guide sheath	Rapid on-site evaluation (ROSE)	Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no guide sheath and the presence of ROSE.

Primary Outcome Measures

Name	Time	Method
Peripheral pulmonary lesion diagnostic yield	1 month

Secondary Outcome Measures

Name	Time	Method
Complications	48 hours	Combination of endpoints following chart review, including but not limited to unplanned hospitalization or emergency room visit, hemoptysis, pneumothorax, chest infection, fever or exacerbation of lung disease.
Sensitivity and specificity for malignancy	weeks up to 1 month
Total procedure time	Intraoperative
Sample adequacy for adjunctive testing if lung cancer	1 month	Sample adequacy for EGFR mutation analysis, ALK and PDL1 immunohistochemistry.
Extra diagnostic procedure required for final diagnosis.	6 months up to 1 year

Trial Locations

Locations (2)

Health Sciences Centre; 🇨🇦 Calgary, Alberta, Canada

Universite Laval; 🇨🇦 Quebec, Canada