Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: EBUS guided FNA with and without suction

• Registration Number: NCT01741571
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-11-27
• Study Start: 2012-12
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-05
• Primary Completion: 2016-01
• Study Completion: 2017-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EBUS guided FNA with suction	EBUS guided FNA with and without 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.
EBUS guided FNA without suction	EBUS guided FNA with and 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.

Primary Outcome Measures

Name	Time	Method
Sensitivity of each needle aspiration technique for diagnosis of malignancy	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	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

Name	Time	Method
Negative predicted value of each needle aspiration technique for diagnosis of malignancy	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.
Positive predicted value of each needle aspiration technique for diagnosis of malignancy	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.
Adequacy of the needle aspiration sample	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.
Specificity of each needle aspiration technique for diagnosis of malignancy	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.

Trial Locations

Locations (1)

American University of Beirut; 🇱🇧 Beirut, Lebanon