Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

NCT ID: NCT01741571

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2017-01-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

EBUS guided FNA with and without suction

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

EBUS guided FNA with and without suction

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hassan Chami

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan Chami, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

AmericanUBMC

Identifier Type: -

Identifier Source: org_study_id