Lung CancerCAPSUNN-EBUSNCT04306614
Capillary Versus Suction Needle Aspiration for Endobronchial Ultrasound (EBUS) Biopsies.
A study testing Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration in people with Lung Cancer and Mediastinal Lymphadenopathy, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Mediastinal Lymphadenopathy, Thoracic Cancer
- What is being tested?
- Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age greater to or equal than 18 years old
- Receiving an endobronchial ultrasound for any diagnostic reason
Who cannot join
- Patients under 18 years old
- Patient refuses consent to undergo endobronchial ultrasound or is incapable of decision making.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration
- Keywords
- Endobronchial Ultrasound, Rapid-Onsite Cytologic Evaluation, Procedure duration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial Ultrasound guided Transbronchial Fine Needle AspirationProcedure or surgery
Bronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Capillary technique | Experimental | Not described Receives: Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration |
| Suction technique | Placebo comparator | Not described Receives: Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ROSE preparations per patient
Measured: During the procedure
Procedure Duration
Measured: During the procedure
Adequacy of ROSE sample (0-1)
Measured: During the procedure
Secondary outcomes (4)
Adequate lymphocyte sampling (0-2)
Measured: During the procedure
Adequate diagnostic cells (0-2)
Measured: During the procedure
Amount of blood contamination on ROSE slide (0-2)
Measured: During the procedure
Adequacy of final specimen for ancillary testing (1-3)
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Apr 2020
- Primary completion20 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inderdeep Dhaliwal, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306614
- Sponsor's protocol ID
- 1
- Acronym
- CAPSUNN-EBUS
- Status last verified
- Feb 2020
- First submitted
- 3 Mar 2020
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capillary Versus Suction Needle Aspiration for Rapid Onsite Cytologic Evaluation in Endobronchial Ultrasound Biopsies
- ClinicalTrials.gov ID
- NCT04306614
- Acronym / sponsor ID
- CAPSUNN-EBUS / 1
- Conditions
- Lung Cancer, Mediastinal Lymphadenopathy, Thoracic Cancer
- Keywords
- Endobronchial Ultrasound, Rapid-Onsite Cytologic Evaluation, Procedure duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capillary technique | Experimental | Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration |
| Suction technique | Placebo comparator | Procedure: Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient age greater to or equal than 18 years old
- Receiving an endobronchial ultrasound for any diagnostic reason
Key exclusion criteria (2 listed)
- Patients under 18 years old
- Patient refuses consent to undergo endobronchial ultrasound or is incapable of decision making.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial Ultrasound guided Transbronchial Fine Needle AspirationBronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance. | Procedure or surgery | Capillary technique, Suction technique |
Primary outcome
Number of ROSE preparations per patient
Time frame: During the procedure
Procedure Duration
Time frame: During the procedure
Adequacy of ROSE sample (0-1)
Time frame: During the procedure
4 secondary outcomes
Adequate lymphocyte sampling (0-2)
Time frame: During the procedure
Adequate diagnostic cells (0-2)
Time frame: During the procedure
Amount of blood contamination on ROSE slide (0-2)
Time frame: During the procedure
Adequacy of final specimen for ancillary testing (1-3)
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inderdeep Dhaliwal principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration in people with Lung Cancer and Mediastinal Lymphadenopathy, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ROSE preparations per patient (time frame: During the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.