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

University of Calgary186 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Interventions

Rapid on-site evaluation (ROSE)PROCEDURE

Pathologist on site for direct evaluation of specimen adequacy

Slim bronchoscope without a guide sheathPROCEDURE

peripheral endobronchial ultrasound performed with a slim bronchoscope (3.0 mm outer diameter with a 1.7mm channel) combined with a radial ultrasound probe but without the use of a guide sheath.

Standard pEBUS with guide sheathPROCEDURE

Using a flexible bronchoscope with minimal outer diameter of 4.2mm.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Peripheral pulmonary lesion diagnostic yield

Time frame: 1 month

Secondary Outcomes

Sensitivity and specificity for malignancy

Time frame: weeks up to 1 month

Total procedure time

Time frame: Intraoperative

Sample adequacy for adjunctive testing if lung cancer

Sample adequacy for EGFR mutation analysis, ALK and PDL1 immunohistochemistry.

Time frame: 1 month

Extra diagnostic procedure required for final diagnosis.

Time frame: 6 months up to 1 year

Complications

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.

Time frame: 48 hours