Capillary Versus Suction Needle Aspiration for Endobronchial Ultrasound (EBUS) Biopsies.

Study Overview
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Brief Summary
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Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration is a procedure used to obtain tissue samples (biopsies) of lymph nodes near the airways or of lung tumours growing in close proximity to the airways. Briefly, an endoscope with an ultrasound probe which is inserted through the mouth and into the airways. Once in the airways, the ultrasound allows for identification of the optimal biopsy site; a hollow biopsy needle is then inserted into the tissue under real-time ultrasound visualization and a sample is extracted. In the investigator's centre, the extracted sample is then immediately subjected to rapid on-site evaluation (ROSE). During the ROSE procedure, a cytotechnologist uses part of the sample to make a limited number direct smears which are then rapidly stained and evaluated under a microscope by the cytotechnologist. The cytotechnologist provides an assessment of the adequacy of the sample for diagnosis. The respirologist performing the EBUS then uses this information to: i) determine whether additional sampling is required, and ii) triage any additional samples for ancillary studies as needed. A final cytopathological diagnosis is established several days later, when all of the material from the procedure (including the material not evaluated at ROSE) is examined by a cytopathologist. There are different techniques which are utilized to perform the needle aspiration biopsy. Suction aspiration (where pressure suction is applied to the needle to draw out material) which is the standard at many centres around the world and capilliary suction (where a tiny wire is drawn back slowly to create more gentle suction force) which is utilized often at LHSC. The purpose of this study is to evaluate for differences in ROSE adequacy between these two methods.

Official Title
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Capillary Versus Suction Needle Aspiration for Rapid Onsite Cytologic Evaluation in Endobronchial Ultrasound Biopsies

Conditions
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Lung Cancer, Mediastinal Lymphadenopathy, Thoracic Cancer

Intervention / Treatment
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* Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age greater to or equal than 18 years old Receiving an endobronchial ultrasound for any diagnostic reason Exclusion Criteria: Patients under 18 years old Patient refuses consent to undergo endobronchial ultrasound or is incapable of decision making.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capillary technique<br> | Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration<br>* Bronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance.<br>|
| Placebo Comparator: Suction technique<br> | Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration<br>* Bronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ROSE preparations per patient |  | During the procedure | 
| Procedure Duration |  | During the procedure | 
| Adequacy of ROSE sample (0-1) |  | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate lymphocyte sampling (0-2) |  | During the procedure | 
| Adequate diagnostic cells (0-2) |  | During the procedure | 
| Amount of blood contamination on ROSE slide (0-2) |  | During the procedure | 
| Adequacy of final specimen for ancillary testing (1-3) |  | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endobronchial Ultrasound, Rapid-Onsite Cytologic Evaluation, Procedure duration