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

Lung Cancer Clinical Trial

— CAPSUNN-EBUS  

Official title:

Capillary Versus Suction Needle Aspiration for Rapid Onsite Cytologic Evaluation in Endobronchial Ultrasound Biopsies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306614
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2020
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 30, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lymphadenopathy
• Mediastinal Lymphadenopathy
• Thoracic Cancer

Intervention

Procedure:
• Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration
Bronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ROSE preparations per patient		During the procedure
Primary	Procedure Duration		During the procedure
Primary	Adequacy of ROSE sample (0-1)		During the procedure
Secondary	Adequate lymphocyte sampling (0-2)		During the procedure
Secondary	Adequate diagnostic cells (0-2)		During the procedure
Secondary	Amount of blood contamination on ROSE slide (0-2)		During the procedure
Secondary	Adequacy of final specimen for ancillary testing (1-3)		During the procedure