Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE)

Study Overview
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Brief Summary
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The objective of this study is comparing the attributable procedural time of Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes will include total number of sampled lymph nodes, average number of needle aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.

Official Title
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Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE) by Cytopathologist

Conditions
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ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy

Intervention / Treatment
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* Procedure: ROSE
* Device: 22 gauge Vizishot needles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject provides informed consent Subject is >18 years of age Subject is scheduled to undergo flexible bronchoscopy with EBUS-TBNA of suspected enlarged mediastinal or hilar lymph nodes as part of their standard medical care A negative pregnancy test in women of child-bearing potential Subject is mentally capable of following study directions Exclusion Criteria: Study subject has any disease or condition that interferes with safe completion of initial or follow-up assessments Concurrent participation in another study involving investigational drugs or investigational medical devices Inability to read and understand the necessary study documents

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ROSE<br>In the case of ROSE, sampling frequency will occur similarly, but no additional samples will be taken in the case of provision of a preliminary diagnosis. | Procedure: ROSE<br>* The procedure will proceed with conventional EBUS-TBNA sampling of the target lesion with 22 gauge Vizishot needles. Each subject will be randomized to either ROSE by cytopathologist or no ROSE.<br>Device: 22 gauge Vizishot needles<br> <br> |
| Other: NO ROSE<br>In the case of no ROSE, sampling frequency will be predetermined at 4 needle aspirations per site | Procedure: ROSE<br>* The procedure will proceed with conventional EBUS-TBNA sampling of the target lesion with 22 gauge Vizishot needles. Each subject will be randomized to either ROSE by cytopathologist or no ROSE.<br>Device: 22 gauge Vizishot needles<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time lapse | The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. | during procedure, approximately 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of sampled lymph nodes | Samples taken during procedure | approximately 45 minutes | 
| Average number of needle aspirations per lymph node sampled | Determined by tumor | approximately 45 minutes | 
| Overall diagnostic yield |  | approximately 45 minutes | 
| Procedural time of the cytopathologist |  | approximately 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enlarged mediastinal nodes, enlarged hilar lymph nodes