Capillary Versus Suction Needle Aspiration for Endobronchial Ultrasound (EBUS) Biopsies.

NCT ID: NCT04306614

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-09-30

Brief Summary

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration is a procedure used to obtain tissue samples (biopsies) of lymph nodes near the airways or of lung tumours growing in close proximity to the airways. Briefly, an endoscope with an ultrasound probe which is inserted through the mouth and into the airways. Once in the airways, the ultrasound allows for identification of the optimal biopsy site; a hollow biopsy needle is then inserted into the tissue under real-time ultrasound visualization and a sample is extracted.

In the investigator's centre, the extracted sample is then immediately subjected to rapid on-site evaluation (ROSE). During the ROSE procedure, a cytotechnologist uses part of the sample to make a limited number direct smears which are then rapidly stained and evaluated under a microscope by the cytotechnologist. The cytotechnologist provides an assessment of the adequacy of the sample for diagnosis. The respirologist performing the EBUS then uses this information to: i) determine whether additional sampling is required, and ii) triage any additional samples for ancillary studies as needed. A final cytopathological diagnosis is established several days later, when all of the material from the procedure (including the material not evaluated at ROSE) is examined by a cytopathologist.

There are different techniques which are utilized to perform the needle aspiration biopsy. Suction aspiration (where pressure suction is applied to the needle to draw out material) which is the standard at many centres around the world and capilliary suction (where a tiny wire is drawn back slowly to create more gentle suction force) which is utilized often at LHSC.

The purpose of this study is to evaluate for differences in ROSE adequacy between these two methods.

Conditions

Lung Cancer; Mediastinal Lymphadenopathy; Thoracic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Capillary technique

Group Type: EXPERIMENTAL

Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration

Intervention Type: PROCEDURE

Bronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance.

Suction technique

Group Type: PLACEBO_COMPARATOR

Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration

Intervention Type: PROCEDURE

Bronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance.

Interventions

Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration

Bronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient age greater to or equal than 18 years old
• Receiving an endobronchial ultrasound for any diagnostic reason

Exclusion Criteria

• Patients under 18 years old
• Patient refuses consent to undergo endobronchial ultrasound or is incapable of decision making.

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

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inderdeep Dhaliwal

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

Countries

Canada

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id