Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

Study Overview
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Brief Summary
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Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques have not been well studied. The investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.

Detailed Description
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Consecutive patients with suspected malignant peribronchial masses or lymph nodes undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be enrolled. All participants will have 4 needle aspirations of each targeted peribronchial lesion. Two needle aspirations will be performed while applying suction and 2 needle aspirations will be performed without applying suction in random order. The investigators will compare the diagnostic yield and the quality of the specimens obtained using the two techniques.

Official Title
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Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: EBUS guided FNA with and without suction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult undergoing EBUS at AUBMC for suspected malignancy Exclusion Criteria: Coagulopathy The lesion cannot be sampled because of intervening tumor or blood vessels.

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: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EBUS guided FNA with suction<br>Device/procedure: lymph node tissue collection using fine needle aspiration with suction applied. Four fine needle aspirations will be taken sequentially from each lymph node. Two with suction and two without suction applied. | Device: EBUS guided FNA with and without suction<br>* Device/procedure: lymph node tissue collection using needle with and without suction applied. Four fine needle aspirations will be taken from each lymph node. Two with suction and two without suction applied.<br>|
| Experimental: EBUS guided FNA without suction<br>Device/procedure: lymph node tissue collection using fine needle aspiration without suction applied. Four fine needle aspirations will be taken sequentially from each lymph node. Two with suction and two without suction applied. | Device: EBUS guided FNA with and without suction<br>* Device/procedure: lymph node tissue collection using needle with and without suction applied. Four fine needle aspirations will be taken from each lymph node. Two with suction and two without suction applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of each needle aspiration technique for diagnosis of malignancy | A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The sensitivity for diagnosing malignancy will be calculated and compared for the two needle aspiration technique. | Diagnosis of malignancy will be ascertained after 6 month clinical follow up | 
| Diagnostic accuracy of each needle aspiration technique for diagnosis of malignancy | A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The diagnostic accuracy for diagnosing malignancy will be assessed and compared for the two needle aspiration technique. | Diagnosis of malignancy will be ascertained after 6 month clinical follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of the needle aspiration sample | A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for adequacy (presence of malignant cells, granuloma or lymphocytes) The number of adequate samples will be compared for the two techniques. | Adequacy will be assessed within 1 week from procedure | 
| Negative predicted value of each needle aspiration technique for diagnosis of malignancy | A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The negative predictive value for lack of malignant cells will be calculated and compared for the two needle aspiration techniques. | Diagnosis of malignancy will be ascertained after 6 month of clinical follow up | 
| Specificity of each needle aspiration technique for diagnosis of malignancy | A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The specificity for diagnosing malignant cells will be calculated and compared for the two needle aspiration techniques. | Diagnosis of malignancy will be ascertained after 6 month clinical follow up | 
| Positive predicted value of each needle aspiration technique for diagnosis of malignancy | A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The positive predictive value for presence of malignant cells will be calculated and compared for the two needle aspiration techniques. | Diagnosis of Malignancy will be ascertained after 6 month of clinical follow up |