Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- American University of Beirut Medical Center
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Sensitivity of each needle aspiration technique for diagnosis of malignancy
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Hassan Chami
Assistant Professor
American University of Beirut Medical Center
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Sensitivity of each needle aspiration technique for diagnosis of malignancy
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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)
- Adequacy of the needle aspiration sample(Adequacy will be assessed within 1 week from procedure)
- Specificity of each needle aspiration technique for diagnosis of malignancy(Diagnosis of malignancy will be ascertained after 6 month clinical follow up)