Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beirut, Lebanon
- American University of Beirut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: EBUS guided FNA with suction
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/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. |
|
Experimental: EBUS guided FNA without suction
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/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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Diagnosis of malignancy will be ascertained after 6 month clinical follow up
|
|
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. |
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
Time Frame: 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.
|
Adequacy will be assessed within 1 week from procedure
|
|
Negative predicted value of each needle aspiration technique for diagnosis of malignancy
Time Frame: 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. |
Diagnosis of malignancy will be ascertained after 6 month of clinical follow up
|
|
Specificity 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 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
Time Frame: 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. |
Diagnosis of Malignancy will be ascertained after 6 month of clinical follow up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hassan Chami, MD, American University of Beirut Medical center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AmericanUBMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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