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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03809169
• Other study ID #: 88888
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 186
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Peripheral Pulmonary Lesions

Intervention

Procedure:
• Rapid on-site evaluation (ROSE)
Pathologist on site for direct evaluation of specimen adequacy
• Slim bronchoscope without a guide sheath
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 sheath
Using a flexible bronchoscope with minimal outer diameter of 4.2mm.

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Calgary	Alberta
Canada	Universite Laval	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Laval University, McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral pulmonary lesion diagnostic yield		1 month
Secondary	Sensitivity and specificity for malignancy		weeks up to 1 month
Secondary	Total procedure time		Intraoperative
Secondary	Sample adequacy for adjunctive testing if lung cancer	Sample adequacy for EGFR mutation analysis, ALK and PDL1 immunohistochemistry.	1 month
Secondary	Extra diagnostic procedure required for final diagnosis.		6 months up to 1 year
Secondary	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.	48 hours