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Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity of each needle aspiration technique for diagnosis of malignancy

Outcome Description:

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.

Outcome Time Frame:

Diagnosis of malignancy will be ascertained after 6 month clinical follow up

Safety Issue:

No

Principal Investigator

Hassan Chami, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

American University of Beirut Medical Center

Authority:

Lebanon: The American University of Beirut and Ministry of Health

Study ID:

AmericanUBMC

NCT ID:

NCT01741571

Start Date:

October 2012

Completion Date:

December 2013

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

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