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Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741571
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Hassan Chami, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: EBUS guided FNA with and without suction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
Study Start Date : December 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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: EBUS 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.


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: EBUS 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.





Primary Outcome Measures :
  1. 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.


  2. 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 Outcome Measures :
  1. 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.

  2. 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.


  3. 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.


  4. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741571


Locations
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Lebanon
American University of Beirut
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Hassan Chami, MD American University of Beirut Medical Center
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Responsible Party: Hassan Chami, Assistant Professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01741571    
Other Study ID Numbers: AmericanUBMC
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020