SarcoidosisNCT03573362
Effect of Needle Size in Diagnostic Yield of EBUS-TBNA in Sarcoidosis and Lymphoma
A study testing ViziShot FLEX 19G needle and Vizishot 22G needle (standard) in people with Sarcoidosis and Lymphoma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The guided FNA by endobronchial ultrasound ( Endobronchial Ultrasound guided transbronchial Needle Aspiration or EBUS-TBNA) is a minimally invasive technique with an established role in the staging of lung cancer 1, and in the evaluation of intrathoracic lymph node metastases from extrathoracic primary cancer2 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Lymphoma, Adenopathy Hilar
- What is being tested?
- ViziShot FLEX 19G needle and Vizishot 22G needle (standard)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to Dec 2025
- 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 t referred for specimens by EBUS -TBNA with clinical and radiological suspicion of sarcoidosis or lymphoma , with pathological lymph node on imaging (small diameter ≥ 1.0 cm CT-scan or hyper metabolism with PET scan) in para-tracheal stations, sub-carinal and / or hilar (stations 2, 4, 7, 10, 11 and 12), right and / or left.
- Lymph nodes with a small diameter of at least 0.5 cm in CT-scan or PET / CT scan performed in the previous 4-6 weeks.
- Patient investigated in the setting of either an initial diagnosis or a suspicion of lymphoma recurrence (post-treatment).
- Patient able to consent to the procedure and to authorize us by written proxy, included in the consent form for the study, to obtain a copy of the subsequent results or radiological (PET, CT-scan, chest X-ray) or histopathological (linked with age sampled of intrathoracic lymph nodes).
- Patient deemed fit to tolerate the procedure.
Who cannot join
- Patient unable to give consent.
- Female patient during pregnancy
- Patient aged under 18.
- Patient with significant coagulopathy ( INR > 1.5 ; platelet count<50 000 / mm 3 ).
- Patient anticoagulated (oral or parenteral) and whose anticoagulation can not be suspended for the procedure.
- Obvious involvement of organ (s) with the possibility of confirming granulomas or suspicious cells of lymphoma by means of a procedure considered less invasive (.. e g, lymph node biopsy of cervical, supraclavicular or inguinal nodes; skin biopsy).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Thomas Vandemoortele, MD, MSc, 514-890-8000 ext. 25151, thomas.vandemoortele@me.com
Thomas Vandemoortele, MD, MSc
About this study
Official title: Prospective Trial Comparing the Diagnostic Yield of Two Different Needle Sizes Used in EBUS-TBNA for Sarcoidosis and Lymphoma
The guided FNA by endobronchial ultrasound ( Endobronchial Ultrasound guided transbronchial Needle Aspiration or EBUS-TBNA) is a minimally invasive technique with an established role in the staging of lung cancer 1, and in the evaluation of intrathoracic lymph node metastases from extrathoracic primary cancer2 . There is also a role in cases of isolated hilar and mediastinal lymph nodes in which the differential diagnosis includes mostly sarcoidosis, lymphoma and tuberculosis. 3
Various studies have evaluated more recently the diagnostic yield of EBUS-TBNA specifically for sarcoidosis 4 and thoracic lymphoma 5-6. Although there is emerging data supporting the usefulness of EBUS-TBNA in the investigation of these two pathologies, the efficacy results vary according to the target populations and certain parameters. Moreover, although a large randomized study demonstrated e superiority of EBUS-TBNA over conventional bronchoscopic sampling methods [ bronchoalveolar lavage (BAL) and trans-bronchial biopsies (TBB ] for the diagnosis of sarcoidosis , 7 the results suggest that there is still room for optimizing the performance of EBUS-TBNA [b] . In the field of lymphoma, obtaining large enough specimens for adequate subtyping also remains a concern. 8
Read more
In order to improve the performance of EBUS -TBNA , new needles have been developed with the aim to provide biopsies for histological evaluation rather than purely cytological. The ViziShot FLEX © (Olympus) 19 gauge needle (19 gauge or 19G) is a large needle, which can provide both tissue and needle aspiration , and has the advantage of being more flexible.
For this study, the investigators want to compare the diagnostic yield of EBUS-TBNA using needle ViziShot FLEX 19G (1.11 mm) with that of the standard 22G needle ( NA-201SX; Olympus) , in the investigation of hilar or mediastinal lymphadenopathy suspected to be sarcoidosis or lymphoma.
- Conditions
- Sarcoidosis, Lymphoma, Adenopathy Hilar
- Being tested
- ViziShot FLEX 19G needle, Vizishot 22G needle (standard)
- Keywords
- sarcoidosis, ebus, endobronchial ultrasound
- Medical subject headings
- Sarcoidosis, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViziShot FLEX 19G needleDevice
EBUS-TBNA using the ViziShot FLEX 19G needle
Vizishot 22G needle (standard)Device
EBUS-TBNA using the Vizishot 22G needle (standard)
| Study group | Role | What they receive |
|---|---|---|
| Vizishot Flexneedle 19G | Experimental | Mediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle Receives: Device: ViziShot FLEX 19G needle |
| Vizishot 22G | Active comparator | Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle Receives: Device: Vizishot 22G needle (standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of EBUS-TBNA
The diagnostic yield of EBUS TBNA with 19G and 22G needle in patients with a final diagnosis of sarcoidosis will be assessed for any difference between the two, using McNemar test on paired proportions.
Measured: 12 months after enrollment of the last patient.
Secondary outcomes (3)
Ease of use.
Evaluate the ease of use of both types of needles. Using a visual analog scale (from 0 most difficult to 10 very easy to use), ease of use of each needle will be assessed and compared for each lymph node.
Measured: 1 week after enrollment of last patient.
Specimen quality
Samples will be considered adequate if the cytologic assessment shows lymphocytes and or definite if the specimen shows epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body). The samples will be classified as: diagnostic, adequate but non-diagnostic, non-diagnostic and not adequate, no specimen
Measured: 1 week after enrollment of last patient
Complications
Complications encountered with both needle sizes will be compared if there is any difference in the rate of complications, specifically pneumothorax, endobronchial bleeding, post-bronchoscopy bleeding, pneumonia, respiratory infection, hospitalization required because of the procedure, respiratory failure, death.
Measured: 1 month after enrollment of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Jan 2019
- Primary completion1 Jan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Vandemoortele, MD, MSc, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573362
- Sponsor's protocol ID
- 2017-6844
- Status last verified
- Feb 2023
- First submitted
- 15 May 2018
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Comparing the Diagnostic Yield of Two Different Needle Sizes Used in EBUS-TBNA for Sarcoidosis and Lymphoma
- ClinicalTrials.gov ID
- NCT03573362
- Acronym / sponsor ID
- 2017-6844
- Conditions
- Sarcoidosis, Lymphoma, Adenopathy Hilar
- Keywords
- sarcoidosis, ebus, endobronchial ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jun 2018 (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.
The guided FNA by endobronchial ultrasound ( Endobronchial Ultrasound guided transbronchial Needle Aspiration or EBUS-TBNA) is a minimally invasive technique with an established role in the staging of lung cancer 1, and in the evaluation of intrathoracic lymph node metastases from extrathoracic primary cancer2 . There is also a role in cases of isolated hilar and mediastinal lymph nodes in which the differential diagnosis includes mostly sarcoidosis, lymphoma and tuberculosis. 3
Various studies have evaluated more recently the diagnostic yield of EBUS-TBNA specifically for sarcoidosis 4 and thoracic lymphoma 5-6. Although there is emerging data supporting the usefulness of EBUS-TBNA in the investigation of these two pathologies, the efficacy results vary according to the target populations and certain parameters. Moreover, although a large randomized study demonstrated e superiority of EBUS-TBNA over conventional bronchoscopic sampling methods [ bronchoalveolar lavage (BAL) and trans-bronchial biopsies (TBB ] for the diagnosis of sarcoidosis , 7 the results suggest that there is still room for optimizing the performance of EBUS-TBNA [b] . In the field of lymphoma, obtaining large enough specimens for adequate subtyping also remains a concern. 8
In order to improve the performance of EBUS -TBNA , new needles have been developed with the aim to provide biopsies for histological evaluation rather than purely cytological. The ViziShot FLEX © (Olympus) 19 gauge needle (19 gauge or 19G) is a large needle, which can provide both tissue and needle aspiration , and has the advantage of being more flexible.
For this study, the investigators want to compare the diagnostic yield of EBUS-TBNA using needle ViziShot FLEX 19G (1.11 mm) with that of the standard 22G needle ( NA-201SX; Olympus) , in the investigation of hilar or mediastinal lymphadenopathy suspected to be sarcoidosis or lymphoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vizishot Flexneedle 19G | Experimental | Device: ViziShot FLEX 19G needleMediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle |
| Vizishot 22G | Active comparator | Device: Vizishot 22G needle (standard)Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient t referred for specimens by EBUS -TBNA with clinical and radiological suspicion of sarcoidosis or lymphoma , with pathological lymph node on imaging (small diameter ≥ 1.0 cm CT-scan or hyper metabolism with PET scan) in para-tracheal stations, sub-carinal and / or hilar (stations 2, 4, 7, 10, 11 and 12), right and / or left.
- Lymph nodes with a small diameter of at least 0.5 cm in CT-scan or PET / CT scan performed in the previous 4-6 weeks.
- Patient investigated in the setting of either an initial diagnosis or a suspicion of lymphoma recurrence (post-treatment).
- Patient able to consent to the procedure and to authorize us by written proxy, included in the consent form for the study, to obtain a copy of the subsequent results or radiological (PET, CT-scan, chest X-ray) or histopathological (linked with age sampled of intrathoracic lymph nodes).
- Patient deemed fit to tolerate the procedure.
Key exclusion criteria (6 listed)
- Patient unable to give consent.
- Female patient during pregnancy
- Patient aged under 18.
- Patient with significant coagulopathy ( INR > 1.5 ; platelet count<50 000 / mm 3 ).
- Patient anticoagulated (oral or parenteral) and whose anticoagulation can not be suspended for the procedure.
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 |
|---|---|---|
| ViziShot FLEX 19G needleEBUS-TBNA using the ViziShot FLEX 19G needle | Device | Vizishot Flexneedle 19G |
| Vizishot 22G needle (standard)EBUS-TBNA using the Vizishot 22G needle (standard) | Device | Vizishot 22G |
Primary outcome
Diagnostic yield of EBUS-TBNA
Time frame: 12 months after enrollment of the last patient.
The diagnostic yield of EBUS TBNA with 19G and 22G needle in patients with a final diagnosis of sarcoidosis will be assessed for any difference between the two, using McNemar test on paired proportions.
3 secondary outcomes
Ease of use.
Time frame: 1 week after enrollment of last patient.
Specimen quality
Time frame: 1 week after enrollment of last patient
Complications
Time frame: 1 month after enrollment of last patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Vandemoortele, MD, MSc principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViziShot FLEX 19G needle and Vizishot 22G needle (standard) in people with Sarcoidosis and Lymphoma, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Feb 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Vandemoortele, MD, MSc (514-890-8000 ext. 25151, thomas.vandemoortele@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of EBUS-TBNA (time frame: 12 months after enrollment of the last patient.). 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 17 Feb 2023.