Status:
NOT_YET_RECRUITING
General Anesthesia vs Conscious Sedation for Radial Endobronchial Ultrasound
Lead Sponsor:
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Conditions:
Lung Cancers
Peripheral Pulmonary Nodules
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The endoscopic investigation of lung lesions is experiencing significant growth with the increasing number of lung cancer screening programs. Peripheral endobronchial ultrasound (pEBUS) is the most wi...
Detailed Description
This is a multicenter randomized clinical trial to compare the diagnostic yield of pEBUS under general anesthesia and conscious sedation in the context of the investigation of peripheral pulmonary les...
Eligibility Criteria
Inclusion
- Age ≥ 18 years and ability to consent
- Peripheral lung lesion less than 5cm in average diameter on axial CT images (A lung lesion will be considered peripheral if it is located beyond the origin of the subsegmental bronchi and presumed not to be visible endoscopically in white light during the evaluation of the CT scan by an interventional pulmonologist.)
- Lesion deemed accessible by pEBUS by an experienced interventional pulmonologist
- Decision by the medical team and the patient to use pEBUS as a diagnostic modality for the lung lesion
Exclusion
- Planned use of electromagnetic navigation, augmented fluoroscopy or robotic bronchoscopy in addition to pEBUS. The use of virtual bronchoscopy planning is permitted
- Presence of suspicious lymph nodes (size ≥ 10mm and/or moderate or greater hypermetabolism) on imaging which are accessible by l-EBUS and for which rapid on-site cytological analysis will be used
- Contraindication to bronchoscopy or biopsies such as an unstable medical condition or uncorrected coagulopathy
- Current pregnancy
- Lack of free and informed consent
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT06950515
Start Date
May 1 2025
End Date
August 1 2029
Last Update
April 30 2025
Active Locations (1)
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1
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5