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

NCT ID: NCT03809169

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2024-09-30

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.

Conditions

Peripheral Pulmonary Lesions; Lung Cancer

Keywords

peripheral endobronchial ultrasound; radial endobronchial ultrasound; guide sheath; ultrathin bronchoscope; peripheral pulmonary lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ROSE with guide sheath

Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique and presence of ROSE

Group Type: EXPERIMENTAL

Rapid on-site evaluation (ROSE)

Intervention Type: PROCEDURE

Pathologist on site for direct evaluation of specimen adequacy

ROSE without guide sheath

Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no guide sheath and the presence of ROSE.

Group Type: EXPERIMENTAL

Rapid on-site evaluation (ROSE)

Intervention Type: PROCEDURE

Pathologist on site for direct evaluation of specimen adequacy

Slim bronchoscope without a guide sheath

Intervention Type: PROCEDURE

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.

Guide sheath without ROSE

Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique but without ROSE.

Group Type: EXPERIMENTAL

Standard pEBUS with guide sheath

Intervention Type: PROCEDURE

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

No guide sheath without ROSE

Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no the guide sheath an without the presence of ROSE.

Group Type: EXPERIMENTAL

Slim bronchoscope without a guide sheath

Intervention Type: PROCEDURE

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.

Interventions

Rapid on-site evaluation (ROSE)

Pathologist on site for direct evaluation of specimen adequacy

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Standard pEBUS with guide sheath

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

Intervention Type: PROCEDURE

Other Intervention Names

Ultrathin bronchoscope with pEBUS

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Tremblay, MDCM

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Health Sciences Centre

Calgary, Alberta, Canada

Universite Laval

Québec, , Canada

Countries

Canada

References

Vakil E, Fortin M, Gonzalez AV, Samy L, Chee AC, Dumoulin E, Dvorakova M, Hergott CA, Khalil M, Lampron N, MacEachern P, Martel S, Shieh B, Simon M, Soumagne T, Terzic T, Tremblay A. Ultrathin Bronchoscopy With Radial Endobronchial Ultrasound and Rapid On-Site Evaluation for the Diagnosis of Peripheral Pulmonary Lesions: A Multicenter Randomized Controlled Factorial Trial. Chest. 2025 May 24:S0012-3692(25)00669-5. doi: 10.1016/j.chest.2025.05.020. Online ahead of print.

Reference Type: DERIVED

PMID: 40419109 (View on PubMed)

Other Identifiers

88888

Identifier Type: -

Identifier Source: org_study_id