EBUS-TBNA vs Flex 19G EBUS-TBNA

Study Overview
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Brief Summary
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This is a prospective randomised diagnostic clinical study to determine whether the use of a new flexible sampling needle can improve the yield of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical reasons as deemed necessary by the managing physician or multidisciplinary team will be randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be performed under local anaesthesia using conscious sedation or general anaesthesia according to usual practice at the trial centre. Specimens will be placed in saline and formalin and forwarded to the pathology laboratory. The specimens will be spun down to create a cell pellet which will undergo cytological and histological examination as per usual protocol at the trial centre.The pathologist, who will be blinded as to which technique was used to obtain the sample, will grade the quality, quantity, and cellularity of the specimens.

Official Title
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Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Flexible 19G Endobronchial Ultrasound Transbronchial Needle (Flex 19G EBUS-TBNA) in the Assessment of Mediastinal and Hilar Lymph-adenopathy: a Randomised Trial

Conditions
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Lymphadenopathy, Lung Cancer, Sarcoidosis, Lymphoma

Intervention / Treatment
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* Device: 21G EBUS-TBNA needle
* Device: Flexible 19G EBUS-TBNA needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for EBUS-TBNA as part of clinical care Lymph nodes larger than 10mm in diameter Age > 18 years written informed consent Exclusion Criteria: Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia) Inability to obtain informed consent

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 |
| --- | --- |
| Active Comparator: EBUS-TBNA<br>Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle | Device: 21G EBUS-TBNA needle<br> <br> |
| Experimental: Flex 19G EBUS-TBNA<br>Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle | Device: Flexible 19G EBUS-TBNA needle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node | Both specimens (cell pellet and tissue fragments) will be assessed by means of a semiquantitative assessment of material (normal lymph node or lesional tissue) present using the formal scoring system described by Mair | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between the two study arms in the percentage of lymph nodes sampled where enough tissue is obtained for complete immunohistochemical and genetic mutation analysis |  | 1 week | 
| The difference in complication rates between the two study arms |  | 1 month | 
| The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis |  | 1 week | 
| The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma |  | 1 week | 
| The difference in sensitivity for detecting sarcoidosis between the two study arms | Sensitivity = True Positives/(True Positives + False Negatives) | 1 week | 
| The difference in sensitivity for detecting lymphoma between the two study arms | Sensitivity = True Positives/(True Positives + False Negatives) | 1 week |