Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: EBUS guided FNA with and without suction

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: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of each needle aspiration technique for diagnosis of malignancy	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	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	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	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	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	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

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Hassan Chami, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No