Suspected SarcoidosisNCT06220526
Comparing Menghini-type Needle and Franseen-type Needle in EBUS-TBNA for Sarcoidosis
A study testing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in people with Suspected Sarcoidosis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This randomized pilot clinical trial aims to examine whether sample collection with Franseen-type needles are effective for the diagnosis of sarcoidosis, as defined by improved sample quality for pathological diagnosis compared to the conventional Menghini-type needle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Sarcoidosis
- What is being tested?
- endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2023to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- -Any adult patient aged 18 years or older with enlarged mediastinal and/or hilar lymph nodes
- (≥10 mm short-axis diameter on a CT scan), suspected as having sarcoidosis based on clinical
- history, physical exam, and other investigations, and booked for EBUS-TBNA.
Who cannot join
- -Patients that are unable to provide informed consent
- Patients with lymphadenopathy strongly suspected to be secondary to other diseases based on
- clinical history, physical exam, and/or other investigations (e.g., lung cancer, lymphoma,
- infection).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 1L7
Judy McConnell, BSc.Hon, CCRP, 416-581-7486, judy.mcconnell@uhn.ca
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About this study
Official title: A Prospective Randomized Clinical Trial Comparing Menghini-type Needle and Franseen-type Needle for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Pathological Diagnosis of Sarcoidosis
This randomized pilot clinical trial aims to examine whether sample collection with Franseen-type needles are effective for the diagnosis of sarcoidosis, as defined by improved sample quality for pathological diagnosis compared to the conventional Menghini-type needle.
Read the detailed description
This study is a prospective randomized control trial. More than 370 lymph nodes from approximately 128 patients with enlarged mediastinal and/or hilar lymph nodes (≥10 mm short-axis diameter on CT scan) and suspected sarcoidosis will be enrolled in this study. This is a single-center study conducted at the Toronto General Hospital.
If consent is obtained, patients will be considered enrolled. The patients will then be assigned to either Menghini-type (the standard needle type in Toronto General Hospital) or Franseen-type needles in a 1:1 ratio with stratified randomization by the availability of rapid on-site cytology evaluation. An automated randomization program will be used to generate the randomization scheme for the study. Samples from mediastinal and hilar lymph nodes will be obtained by EBUS-guided Menghini-type or Franseen-type needle biopsy. Post-procedural assessment will take place in the endoscopy recovery room and will include, but not limited to, monitoring of vital signs, signs of bleeding, and pulmonary status. As EBUS-TBNA is an outpatient procedure, patients will be discharged home after the procedure.
Specimens (cell pellet and/or tissue fragment) will be assessed by pathologists as per their usual practice. The pathologists will remain blinded to the allocated needle. Specimens will be classified by their adequacy for histological assessment and diagnostic yield. In addition, total procedure time and mean number of needle passes to obtain tissue samples will be compared between the two study arms.
- Conditions
- Suspected Sarcoidosis
- Being tested
- endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)Device
Transbronchial biopsy with Menghini-type or Franseen type Needle
| Study group | Role | What they receive |
|---|---|---|
| Menghini-type needle | Other | the standard needle type Receives: Device: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) |
| Franseen-type needles | Active comparator | the active comparator arm Receives: Device: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adequate tissue sampling from lymph nodes (as determined by pathologists)
To compare the performance characteristics of endobronchial ultrasound-guided transbronchial needle aspiration with Menghini-type needle and Franseen-type needle
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start18 Aug 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected SarcoidosisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuhiro Yasufuku, University Health Network, Toronto
- Investigators
- Kazuhiro Yasufuku, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220526
- Sponsor's protocol ID
- 23-5265
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2023
- Last updated
- 1 May 2026
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial Comparing Menghini-type Needle and Franseen-type Needle for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Pathological Diagnosis of Sarcoidosis
- ClinicalTrials.gov ID
- NCT06220526
- Acronym / sponsor ID
- 23-5265
- Conditions
- Suspected Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Jan 2024 (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.
This randomized pilot clinical trial aims to examine whether sample collection with Franseen-type needles are effective for the diagnosis of sarcoidosis, as defined by improved sample quality for pathological diagnosis compared to the conventional Menghini-type needle.
Detailed description
This study is a prospective randomized control trial. More than 370 lymph nodes from approximately 128 patients with enlarged mediastinal and/or hilar lymph nodes (≥10 mm short-axis diameter on CT scan) and suspected sarcoidosis will be enrolled in this study. This is a single-center study conducted at the Toronto General Hospital.
If consent is obtained, patients will be considered enrolled. The patients will then be assigned to either Menghini-type (the standard needle type in Toronto General Hospital) or Franseen-type needles in a 1:1 ratio with stratified randomization by the availability of rapid on-site cytology evaluation. An automated randomization program will be used to generate the randomization scheme for the study. Samples from mediastinal and hilar lymph nodes will be obtained by EBUS-guided Menghini-type or Franseen-type needle biopsy. Post-procedural assessment will take place in the endoscopy recovery room and will include, but not limited to, monitoring of vital signs, signs of bleeding, and pulmonary status. As EBUS-TBNA is an outpatient procedure, patients will be discharged home after the procedure.
Specimens (cell pellet and/or tissue fragment) will be assessed by pathologists as per their usual practice. The pathologists will remain blinded to the allocated needle. Specimens will be classified by their adequacy for histological assessment and diagnostic yield. In addition, total procedure time and mean number of needle passes to obtain tissue samples will be compared between the two study arms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menghini-type needle | Other | Device: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)the standard needle type |
| Franseen-type needles | Active comparator | Device: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)the active comparator arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -Any adult patient aged 18 years or older with enlarged mediastinal and/or hilar lymph nodes
- (≥10 mm short-axis diameter on a CT scan), suspected as having sarcoidosis based on clinical
- history, physical exam, and other investigations, and booked for EBUS-TBNA.
Key exclusion criteria (4 listed)
- -Patients that are unable to provide informed consent
- clinical history, physical exam, and/or other investigations (e.g., lung cancer, lymphoma,
- infection).
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 needle aspiration (EBUS-TBNA)Transbronchial biopsy with Menghini-type or Franseen type Needle | Device | Franseen-type needles, Menghini-type needle |
Primary outcome
Rate of adequate tissue sampling from lymph nodes (as determined by pathologists)
Time frame: 3 years
To compare the performance characteristics of endobronchial ultrasound-guided transbronchial needle aspiration with Menghini-type needle and Franseen-type needle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- 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.
Kazuhiro Yasufuku principal investigator
UHN
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 needle aspiration (EBUS-TBNA) in people with Suspected Sarcoidosis, run by University Health Network, Toronto 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judy McConnell (416-581-7849, judy.mcconnell@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adequate tissue sampling from lymph nodes (as determined by pathologists) (time frame: 3 years). 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 1 May 2026.