RCT Comparing 19Ga vs 22Ga EBUS-TBNA Needles in Carcinoma.

Study Overview
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Brief Summary
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EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure adequate histological samples. Although a larger 19 Ga needle can procure histological samples as demonstrated by the conventional 19 Ga needle, published data are not existing with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the performance of both needle types.

Detailed Description
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All patients with (suspected) stage IV lung carcinoma identified on spiral computed tomography scan and requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis, subtyping and genotyping of lung cancer are eligible for participation in this study. Procedural technique : patients undergo an EBUS-TBNA procedure with either the Flex 19 Ga needle or the 22 Ga needle ; all procedures are performed using a linear array echoendosope under moderate sedation (standard practice). Primary endpoint of the study is the presence of core tissue that is defined as a continuous string of material as observed on the microscopic examination. Secondary endpoints are elements relevant to molecular analysis.

Official Title
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Randomized Controlled Trial Comparing the Performance of 19 Gauge Versus 22 Gauge EBUS-TBNA Needles in Lung Carcinoma

Conditions
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Lung Neoplasm

Intervention / Treatment
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* Device: EBUS-TBNA needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (suspected) stage IV lung carcinoma identified on spiral computed tomography scan requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis Exclusion Criteria: uncontrolled coagulopathy tracheal stenosis

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 |
| --- | --- |
| Experimental: 19 Ga EBUS-TBNA needle<br>needle aspiration by a flexible 19 Ga needle (Olympus) | Device: EBUS-TBNA needle<br>* tissue sampling<br>|
| Active Comparator: 22 Ga EBUS-TBNA needle<br>needle aspiration by a 22 Ga needle (Olympus) | Device: EBUS-TBNA needle<br>* tissue sampling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue core | Descriptive tissue characteristics of tumor sample | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor cellularity per area of diagnostic tissue | Objective pathologic measurement of tumor density | 14 months | 
| Quantity of DNA extracted | Objective measurement of the amount of DNA | 14 months | 
| Success rate of Next Generation Sequencing | Feasibility of NGS testing | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EBUS-TBNA