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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Thoracic Cancer; Mediastinal Lymphadenopathy
• Intervention / Treatment: Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre - Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Capillary technique	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.
PLACEBO_COMPARATOR: Suction technique	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of ROSE preparations per patient	During the procedure
Procedure Duration	During the procedure
Adequacy of ROSE sample (0-1)	During the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Inderdeep Dhaliwal, Assistant Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2020
• Primary Completion (ACTUAL): September 20, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (ACTUAL): March 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Endobronchial Ultrasound; Rapid-Onsite Cytologic Evaluation; Procedure duration
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No