Clinical trial NCT03809169: Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath
Official title: Rapid On-site Evaluation and Use of a Slim Bronchoscope During Peripheral Endobronchial Ultrasonography for the Investigation of Peripheral Pulmonary Lesion - A Randomized Controlled Factorial Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Pulmonary Lesions
Lung Cancer
Keywords: peripheral endobronchial ultrasound
radial endobronchial ultrasound
guide sheath
ultrathin bronchoscope
peripheral pulmonary lesion
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: McGill University
name: Laval University
First posted: 2019-01-18
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Peripheral pulmonary lesion diagnostic yield
timeFrame: 1 month
Secondary outcomes:
measure: Sensitivity and specificity for malignancy
timeFrame: weeks up to 1 month
measure: Total procedure time
timeFrame: Intraoperative
measure: Sample adequacy for adjunctive testing if lung cancer
timeFrame: 1 month
measure: Extra diagnostic procedure required for final diagnosis.
timeFrame: 6 months up to 1 year
measure: Complications
timeFrame: 48 hours
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Health Sciences Centre
state: Alberta
city: Quebec
country: Canada
facility: Universite Laval
Study officials:
affiliation: University of Calgary
name: Alain Tremblay, MDCM
role: PRINCIPAL_INVESTIGATOR
References: