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Completed

NCT Number: NCT04306614

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of ROSE preparations per patient

    Time frame: During the procedure

  2. Procedure Duration

    Time frame: During the procedure

  3. Adequacy of ROSE sample (0-1)

    Time frame: During the procedure

Secondary outcomes

  1. Adequate lymphocyte sampling (0-2)

    Time frame: During the procedure

  2. Adequate diagnostic cells (0-2)

    Time frame: During the procedure

  3. Amount of blood contamination on ROSE slide (0-2)

    Time frame: During the procedure

  4. Adequacy of final specimen for ancillary testing (1-3)

    Time frame: During the procedure

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Acronym: CAPSUNN-EBUS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2020
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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