Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

Lung Cancer Clinical Trial

Official title:

Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741571
• Other study ID #: AmericanUBMC
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: January 2017

Study information

• Verified date: September 2020
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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