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OpenTrials
Completed

NCT Number: NCT03809169

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Rapid on-site evaluation (ROSE)

Procedure

Pathologist on site for direct evaluation of specimen adequacy

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.

Other names: Ultrathin bronchoscope with pEBUS

Standard pEBUS with guide sheath

Procedure

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

Primary outcomes

  1. Peripheral pulmonary lesion diagnostic yield

    Time frame: 1 month

Secondary outcomes

  1. Sensitivity and specificity for malignancy

    Time frame: weeks up to 1 month

  2. Total procedure time

    Time frame: Intraoperative

  3. Sample adequacy for adjunctive testing if lung cancer

    Time frame: 1 month

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

  4. Extra diagnostic procedure required for final diagnosis.

    Time frame: 6 months up to 1 year

  5. Complications

    Time frame: 48 hours

    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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Laval University
  • McGill University

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2019
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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