General anesthesia versus conscious sedation for radial endobronchial ultrasound

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, multicenter trial comparing diagnostic yield of peripheral radial endobronchial ultrasound (pEBUS) performed under general anesthesia versus conscious sedation. Adults with peripheral lung lesions deemed accessible by experienced interventional pulmonologists are randomized to one of the two sedation strategies and undergo pEBUS with standard sampling techniques. Patient comfort questionnaires are collected before discharge and final pathology and procedure outcomes are reviewed from the medical record about one month after the procedure. Key exclusions include planned use of electromagnetic navigation/robotic bronchoscopy, suspicious mediastinal lymph nodes requiring EBUS-TBNA, or contraindications to bronchoscopy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Presence of multiple lung lesions with sampling of more than one lung lesion planned
* 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 or lactation
* Lack of free and informed consent

Where it's running

• Institut universitaire de cardiologie et de pneumologie de Québec
  Québec, Quebec, Canada Recruiting
• Sotiria Thoracic Diseases Hospital of Athens
  Athens, Greece Recruiting
• St. Elisabethen Hospital Frankfurt
  Frankfurt am Main, Hesse, Germany Not yet recruiting
• Hospital Universitario Central de Asturias
  Oviedo, Principality of Asturias, Spain Not yet recruiting

Study contacts

• Study coordinator: Marc Fortin, MD
• Email: marc.fortin@criucpq.ulaval.ca
• Phone: 418-656-8711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.