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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

Tracking Information
First Submitted Date  ICMJE November 27, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date September 21, 2020
Study Start Date  ICMJE December 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
Official Title  ICMJE Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Lung Cancer
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.

    Intervention: Device: EBUS guided FNA with and without suction
  • 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.

    Intervention: Device: EBUS guided FNA with and without suction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
50
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741571
Other Study ID Numbers  ICMJE AmericanUBMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hassan Chami, American University of Beirut Medical Center
Study Sponsor  ICMJE American University of Beirut Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hassan Chami, MD American University of Beirut Medical Center
PRS Account American University of Beirut Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP