LymphadenopathyNCT02592837
EBUS-TBNA vs Flex 19G EBUS-TBNA
A study testing Flexible 19G EBUS-TBNA needle and 21G EBUS-TBNA needle in people with Lymphadenopathy and Lung Cancer, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (EBUS-TBNA) is an excellent tool for sampling enlarged mediastinal and hilar lymph nodes, but only provides needle aspirate samples which are often adequate for cytological examination only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphadenopathy, Lung Cancer, Sarcoidosis
- What is being tested?
- Flexible 19G EBUS-TBNA needle and 21G EBUS-TBNA needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to 14 Dec 2017
- 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
- Scheduled for EBUS-TBNA as part of clinical care
- Lymph nodes larger than 10mm in diameter
- Age > 18 years
- Written informed consent
Who cannot join
- Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
- Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Flexible 19G Endobronchial Ultrasound Transbronchial Needle (Flex 19G EBUS-TBNA) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
Endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (EBUS-TBNA) is an excellent tool for sampling enlarged mediastinal and hilar lymph nodes, but only provides needle aspirate samples which are often adequate for cytological examination only. More advanced histopathological and immunocytopathological assessment of tissue samples, which is particularly important in the diagnosis and staging of cancer, is often not possible with the small cellular samples obtained by EBUS-TBNA. A new transbronchial nodal aspiration needle (the Flex 19G EBUS-TBNA needle) has been developed with a larger needle diameter and more flexibility at the distal end, allowing better access to some lymph nodes stations. This needle can be passed down an EBUS scope and can hypothetically circumvent the deficiencies of EBUS-TBNA highlighted above by providing tissue adequate for histological assessment rather than cytological assessment alone.
This study aims to establish whether the use of the Flex 19G EBUS-TBNA needle can improve the diagnostic yield of EBUS sampling procedures compared to the use of the conventional TBNA needle, thereby allowing more accurate diagnoses and reducing the need repeat procedures or more invasive surgical biopsies, without causing an increase in complication rates. Patients with enlarged mediastinal and hilar lymph nodes referred for EBUS-TBNA will be randomised to have their nodes sampled by either the EBUS-TBNA needle (conventional procedure) or the novel Flex 19G EBUS-TBNA needle. The investigators hope to recruit 250 patients over a 24 month period.
- Conditions
- Lymphadenopathy, Lung Cancer, Sarcoidosis, Lymphoma
- Being tested
- Flexible 19G EBUS-TBNA needle, 21G EBUS-TBNA needle
- Keywords
- Endobronchial ultrasound, EBUS, TBNA, Mediastinal ymphadenopathy, Hilar lymphadenopathy, Lung cancer
- Medical subject headings
- Lymphadenopathy, Lung Neoplasms, Sarcoidosis, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible 19G EBUS-TBNA needleDevice
21G EBUS-TBNA needleDevice
| Study group | Role | What they receive |
|---|---|---|
| Flex 19G EBUS-TBNA | Experimental | Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle Receives: Device: Flexible 19G EBUS-TBNA needle |
| EBUS-TBNA | Active comparator | Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle Receives: Device: 21G EBUS-TBNA needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
Both specimens (cell pellet and tissue fragments) will be assessed by means of a semiquantitative assessment of material (normal lymph node or lesional tissue) present using the formal scoring system described by Mair.
Measured: 1 week
Secondary outcomes (6)
The difference between the two study arms in the percentage of lymph nodes sampled where enough tissue is obtained for complete immunohistochemical and genetic mutation analysis.
Measured: 1 week
The difference in complication rates between the two study arms
Measured: 1 month
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis
Measured: 1 week
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma
Measured: 1 week
The difference in sensitivity for detecting sarcoidosis between the two study arms
Sensitivity = True Positives/(True Positives + False Negatives)
Measured: 1 week
The difference in sensitivity for detecting lymphoma between the two study arms
Sensitivity = True Positives/(True Positives + False Negatives)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startMay 2016
- Primary completion14 Nov 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphadenopathyStudies of the same condition, open and under way.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Corporation
- Responsible party
- Sponsor
- Investigators
- Pallav L Shah, MBBS MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592837
- Sponsor's protocol ID
- 2015LF016B
- Status last verified
- May 2018
- First submitted
- 28 Oct 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Flexible 19G Endobronchial Ultrasound Transbronchial Needle (Flex 19G EBUS-TBNA) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
- ClinicalTrials.gov ID
- NCT02592837
- Acronym / sponsor ID
- 2015LF016B
- Conditions
- Lymphadenopathy, Lung Cancer, Sarcoidosis, Lymphoma
- Keywords
- Endobronchial ultrasound, EBUS, TBNA, Mediastinal ymphadenopathy, Hilar lymphadenopathy, Lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Olympus Corporation
- Study start
- May 2016
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 30 Oct 2015 (estimated)
- 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 (EBUS-TBNA) is an excellent tool for sampling enlarged mediastinal and hilar lymph nodes, but only provides needle aspirate samples which are often adequate for cytological examination only. More advanced histopathological and immunocytopathological assessment of tissue samples, which is particularly important in the diagnosis and staging of cancer, is often not possible with the small cellular samples obtained by EBUS-TBNA. A new transbronchial nodal aspiration needle (the Flex 19G EBUS-TBNA needle) has been developed with a larger needle diameter and more flexibility at the distal end, allowing better access to some lymph nodes stations. This needle can be passed down an EBUS scope and can hypothetically circumvent the deficiencies of EBUS-TBNA highlighted above by providing tissue adequate for histological assessment rather than cytological assessment alone.
This study aims to establish whether the use of the Flex 19G EBUS-TBNA needle can improve the diagnostic yield of EBUS sampling procedures compared to the use of the conventional TBNA needle, thereby allowing more accurate diagnoses and reducing the need repeat procedures or more invasive surgical biopsies, without causing an increase in complication rates. Patients with enlarged mediastinal and hilar lymph nodes referred for EBUS-TBNA will be randomised to have their nodes sampled by either the EBUS-TBNA needle (conventional procedure) or the novel Flex 19G EBUS-TBNA needle. The investigators hope to recruit 250 patients over a 24 month period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flex 19G EBUS-TBNA | Experimental | Device: Flexible 19G EBUS-TBNA needleMediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle |
| EBUS-TBNA | Active comparator | Device: 21G EBUS-TBNA needleMediastinal and hilar lymph node sampling using a standard 21G 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 (4 listed)
- Scheduled for EBUS-TBNA as part of clinical care
- Lymph nodes larger than 10mm in diameter
- Age > 18 years
- Written informed consent
Key exclusion criteria (2 listed)
- Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
- Inability to obtain informed consent
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 |
|---|---|---|
| Flexible 19G EBUS-TBNA needle | Device | Flex 19G EBUS-TBNA |
| 21G EBUS-TBNA needle | Device | EBUS-TBNA |
Primary outcome
The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
Time frame: 1 week
Both specimens (cell pellet and tissue fragments) will be assessed by means of a semiquantitative assessment of material (normal lymph node or lesional tissue) present using the formal scoring system described by Mair.
6 secondary outcomes
The difference between the two study arms in the percentage of lymph nodes sampled where enough tissue is obtained for complete immunohistochemical and genetic mutation analysis.
Time frame: 1 week
The difference in complication rates between the two study arms
Time frame: 1 month
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis
Time frame: 1 week
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma
Time frame: 1 week
The difference in sensitivity for detecting sarcoidosis between the two study arms
Time frame: 1 week
The difference in sensitivity for detecting lymphoma between the two study arms
Time frame: 1 week
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 11 May 2018.
- 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.
Pallav L Shah, MBBS MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible 19G EBUS-TBNA needle and 21G EBUS-TBNA needle in people with Lymphadenopathy and Lung Cancer, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 4 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 11 May 2018. 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 United Kingdom. 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?
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?
The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node (time frame: 1 week). 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 11 May 2018.