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

Primary Purpose

Lung Cancer, Mediastinal Lymphadenopathy, Thoracic Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Endobronchial Ultrasound, Rapid-Onsite Cytologic Evaluation, Procedure duration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Centre - Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Capillary technique

Suction technique

Arm Description

Outcomes

Primary Outcome Measures

Number of ROSE preparations per patient
Procedure Duration
Adequacy of ROSE sample (0-1)

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2020
Last Updated
April 6, 2021
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04306614
Brief Title
Capillary Versus Suction Needle Aspiration for Endobronchial Ultrasound (EBUS) Biopsies.
Acronym
CAPSUNN-EBUS
Official Title
Capillary Versus Suction Needle Aspiration for Rapid Onsite Cytologic Evaluation in Endobronchial Ultrasound Biopsies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Mediastinal Lymphadenopathy, Thoracic Cancer
Keywords
Endobronchial Ultrasound, Rapid-Onsite Cytologic Evaluation, Procedure duration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capillary technique
Arm Type
Experimental
Arm Title
Suction technique
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration
Intervention Description
Bronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance.
Primary Outcome Measure Information:
Title
Number of ROSE preparations per patient
Time Frame
During the procedure
Title
Procedure Duration
Time Frame
During the procedure
Title
Adequacy of ROSE sample (0-1)
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Adequate lymphocyte sampling (0-2)
Time Frame
During the procedure
Title
Adequate diagnostic cells (0-2)
Time Frame
During the procedure
Title
Amount of blood contamination on ROSE slide (0-2)
Time Frame
During the procedure
Title
Adequacy of final specimen for ancillary testing (1-3)
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inderdeep Dhaliwal
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre - Victoria Hospital
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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