Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04306614
Acronym
CAPSUNN-EBUS
Enrollment
118
Registered
2020-03-13
Start date
2020-04-01
Completion date
2020-09-30
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Mediastinal Lymphadenopathy, Thoracic Cancer

Keywords

Endobronchial Ultrasound, Rapid-Onsite Cytologic Evaluation, Procedure duration

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.

Interventions

PROCEDUREEndobronchial Ultrasound guided Transbronchial Fine Needle Aspiration

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

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of ROSE preparations per patientDuring the procedure
Procedure DurationDuring the procedure
Adequacy of ROSE sample (0-1)During the procedure

Secondary

MeasureTime frame
Adequate lymphocyte sampling (0-2)During the procedure
Adequacy of final specimen for ancillary testing (1-3)During the procedure
Adequate diagnostic cells (0-2)During the procedure
Amount of blood contamination on ROSE slide (0-2)During the procedure

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026