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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS guided FNA with suction | Active Comparator | 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. |
|
| EBUS guided FNA without suction | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS guided FNA with and without suction | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Chami, MD | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013396 | Suction |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |