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

NCT04306614 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Mediastinal Lymphadenopathy; Thoracic Cancer

Keywords

Endobronchial Ultrasound; Rapid-Onsite Cytologic Evaluation; Procedure duration

Outcome Measures

Primary Outcomes (3)

• Number of ROSE preparations per patient

  During the procedure

• Procedure Duration

  During the procedure

• Adequacy of ROSE sample (0-1)

  During the procedure

Secondary Outcomes (4)

• 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

Study Arms (2)

Capillary technique

EXPERIMENTAL

Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration

Suction technique

PLACEBO COMPARATOR

Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration

Interventions

Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration PROCEDURE

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

Capillary technique; Suction technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age greater to or equal than 18 years old
• Receiving an endobronchial ultrasound for any diagnostic reason

You may not qualify if:

• Patients under 18 years old
• Patient refuses consent to undergo endobronchial ultrasound or is incapable of decision making.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Inderdeep Dhaliwal

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 13, 2020
• Study Start: April 1, 2020
• Primary Completion: September 20, 2020
• Study Completion: September 30, 2020
• Last Updated: April 12, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)