Lung Cancer
Conditions
Brief summary
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
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.
Interventions
DEVICEEBUS guided FNA with and without suction
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.
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of each needle aspiration technique for diagnosis of malignancy | Diagnosis of malignancy will be ascertained after 6 month clinical follow up | 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. |
| Diagnostic accuracy of each needle aspiration technique for diagnosis of malignancy | Diagnosis of malignancy will be ascertained after 6 month clinical follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of the needle aspiration sample | Adequacy will be assessed within 1 week from procedure | 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. |
| Negative predicted value of each needle aspiration technique for diagnosis of malignancy | Diagnosis of malignancy will be ascertained after 6 month of clinical follow up | 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. |
| Specificity of each needle aspiration technique for diagnosis of malignancy | Diagnosis of malignancy will be ascertained after 6 month clinical follow up | 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. |
| Positive predicted value of each needle aspiration technique for diagnosis of malignancy | Diagnosis of Malignancy will be ascertained after 6 month of clinical follow up | 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. |
Countries
Lebanon
Outcome results
None listed