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

NCT03809169 | Completed

• 1 other identifier: 88888
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Peripheral pulmonary lesion diagnostic yield

  1 month

Secondary Outcomes (5)

• Sensitivity and specificity for malignancy

  weeks up to 1 month

• Total procedure time

  Intraoperative

• Sample adequacy for adjunctive testing if lung cancer

  1 month

• Extra diagnostic procedure required for final diagnosis.

  6 months up to 1 year

• Complications

  48 hours

Study Arms (4)

ROSE with guide sheath

EXPERIMENTAL

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

Procedure: Rapid on-site evaluation (ROSE)

ROSE without guide sheath

EXPERIMENTAL

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

Procedure: Rapid on-site evaluation (ROSE); Procedure: Slim bronchoscope without a guide sheath

Guide sheath without ROSE

EXPERIMENTAL

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

Procedure: Standard pEBUS with guide sheath

No guide sheath without ROSE

EXPERIMENTAL

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.

Procedure: Slim bronchoscope without a guide sheath

Interventions

Rapid on-site evaluation (ROSE) PROCEDURE

Pathologist on site for direct evaluation of specimen adequacy

ROSE with guide sheath; ROSE without guide sheath

Slim bronchoscope without a guide sheath 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.

Also known as: Ultrathin bronchoscope with pEBUS

No guide sheath without ROSE; ROSE without guide sheath

Standard pEBUS with guide sheath PROCEDURE

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

Guide sheath without ROSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years old
• Presence of a peripheral pulmonary lesion (PPL) of ≤5cm (mean short-long on axial CT) suspicious for malignancy.
• The PPL appears radiologically accessible via pEBUS as assessed by an experienced interventional respirologist.
• 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.
• Clinical decision made by patient and treating physician to proceed to bronchoscopy.

You may not qualify if:

• Other intervention indicated as primary diagnostic procedure (eg: TTNA, surgical lung biopsy, linear EBUS alone, biopsy of extra-thoracic lesion)
• Location of lesion not amenable to transbronchial needle aspiration sampling as assessed by an experienced interventional respirologist.
• 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.
• Pregnancy
• Use of electromagnetic or other navigation system (virtual bronchoscopic planning is allowed)
• Absence of informed consent.

Sponsors & Collaborators

• University of Calgary: lead
• McGill University: collaborator
• Laval University: collaborator

Study Sites (2)

Health Sciences Centre

Calgary, Alberta, T2N 4N1, Canada

Location

Universite Laval

Québec, Canada

Location

Related Publications (1)

• 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 Oct;168(4):1034-1048. doi: 10.1016/j.chest.2025.05.020. Epub 2025 May 24.

  PMID: 40419109 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Rapid On-site Evaluation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Alain Tremblay, MDCM

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 18, 2019
• Study Start: November 1, 2019
• Primary Completion: March 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following article publication
• Access Criteria: Shared with researchers who will provide a methodologically sound proposal.

Locations

CA (2)