Status:
COMPLETED
Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
McGill University
Laval University
Conditions:
Peripheral Pulmonary Lesions
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 patholo...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years old
- Presence of a peripheral pulmonary lesion (PPL) of ≤5cm (mean short-long on axial CT) suspicious for malignancy.
- The PPL appears radiologically accessible via pEBUS as assessed by an experienced interventional respirologist.
- 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.
- Clinical decision made by patient and treating physician to proceed to bronchoscopy.
Exclusion
- Other intervention indicated as primary diagnostic procedure (eg: TTNA, surgical lung biopsy, linear EBUS alone, biopsy of extra-thoracic lesion)
- Location of lesion not amenable to transbronchial needle aspiration sampling as assessed by an experienced interventional respirologist.
- 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.
- Pregnancy
- Use of electromagnetic or other navigation system (virtual bronchoscopic planning is allowed)
- Absence of informed consent.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03809169
Start Date
November 1 2019
End Date
September 30 2024
Last Update
December 5 2024
Active Locations (2)
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1
Health Sciences Centre
Calgary, Alberta, Canada, T2N 4N1
2
Universite Laval
Québec, Canada