Clinical trial NCT04306614: Capillary Versus Suction Needle Aspiration for Endobronchial Ultrasound (EBUS) Biopsies.
Official title: Capillary Versus Suction Needle Aspiration for Rapid Onsite Cytologic Evaluation in Endobronchial Ultrasound Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Mediastinal Lymphadenopathy
Thoracic Cancer
Keywords: Endobronchial Ultrasound
Rapid-Onsite Cytologic Evaluation
Procedure duration
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Number of ROSE preparations per patient
timeFrame: During the procedure
measure: Procedure Duration
timeFrame: During the procedure
measure: Adequacy of ROSE sample (0-1)
timeFrame: During the procedure
Secondary outcomes:
measure: Adequate lymphocyte sampling (0-2)
timeFrame: During the procedure
measure: Adequate diagnostic cells (0-2)
timeFrame: During the procedure
measure: Amount of blood contamination on ROSE slide (0-2)
timeFrame: During the procedure
measure: Adequacy of final specimen for ancillary testing (1-3)
timeFrame: During the procedure
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
state: Ontario
Study officials:
affiliation: Assistant Professor
name: Inderdeep Dhaliwal
role: PRINCIPAL_INVESTIGATOR
References: