Mediastinal LymphadenopathyNCT01467635
EBUS-TBNA Versus EBUS-TBNB
A study testing Endobronchial ultrasound guided lymph node sampling in people with Mediastinal Lymphadenopathy and Hilar Lymphadenopathy, run by Royal Brompton & Harefield NHS Foundation Trust at 3 sites in 2 countries.
Trial summary
A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Carcinoma
- What is being tested?
- Endobronchial ultrasound guided lymph node sampling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2014to Jul 2016
- 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
- Able to provide written informed consent
Who cannot join
- Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
- Inability to obtain informed consent
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Chelsea and Westminster Hospital
London, SW10 9NH
The Royal Brompton Hospital
London, SW3 6NP
About this study
Official title: Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).
The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
- Conditions
- Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Carcinoma, Lymphoma, Sarcoidosis, Mycobacterial Disease
- Being tested
- Endobronchial ultrasound guided lymph node sampling
- Keywords
- Endobronchial ultrasound, Transbronchial needle aspiration, Transbronchial biopsy forceps, Mediastinal lymphadenopathy, Hilar lymphadenopathy
- Medical subject headings
- Carcinoma, Lymphoma, Sarcoidosis, Mycobacterium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial ultrasound guided lymph node samplingDevice
Also called Olympus EBUS-TBNA needle, Olympus EBUS-TBNB biopsy forceps
Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNA | Active comparator | Sampling using endobronchial ultrasound guided transbronchial needle aspiration Receives: Device: Endobronchial ultrasound guided lymph node sampling |
| EBUS-TBNB | Experimental | Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle. Receives: Device: Endobronchial ultrasound guided lymph node sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below:
- Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour.
- Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas.
- Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium.
Measured: 18 months
Secondary outcomes (1)
The difference in the complication rate between the two study arms
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startMay 2014
- Primary completionJul 2016
- Study completionJul 2016 (estimated)
Why it stopped: Manufacturer did not develop and deliver the necessary biopsy forceps needles in time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal 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, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Chelsea and Westminster NHS Foundation Trust, Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Zaid Zoumot, MBBS, MRCP, MSc, Study director, Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation TrustPallav L Shah, MD, FRCP, Principal investigator, Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467635
- Sponsor's protocol ID
- 2011PA002B
- Status last verified
- Jul 2016
- First submitted
- 4 Nov 2011
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
- ClinicalTrials.gov ID
- NCT01467635
- Acronym / sponsor ID
- 2011PA002B
- Conditions
- Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Carcinoma, Lymphoma, Sarcoidosis, Mycobacterial Disease
- Keywords
- Endobronchial ultrasound, Transbronchial needle aspiration, Transbronchial biopsy forceps, Mediastinal lymphadenopathy, Hilar lymphadenopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Manufacturer did not develop and deliver the necessary biopsy forceps needles in time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Chelsea and Westminster NHS Foundation Trust, Heidelberg University
- Study start
- May 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (estimated)
- First posted
- 9 Nov 2011 (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.
A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).
The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA | Active comparator | Device: Endobronchial ultrasound guided lymph node samplingSampling using endobronchial ultrasound guided transbronchial needle aspiration |
| EBUS-TBNB | Experimental | Device: Endobronchial ultrasound guided lymph node samplingSampling using endobronchial ultrasound guided transbronchial forceps biopsy 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
- Able to provide written informed consent
Key exclusion criteria (2 listed)
- Contraindications for needle or forceps 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 |
|---|---|---|
| Endobronchial ultrasound guided lymph node samplingAlso: Olympus EBUS-TBNA needle, Olympus EBUS-TBNB biopsy forcepsPatients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps. | Device | EBUS-TBNA, EBUS-TBNB |
Primary outcome
The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
Time frame: 18 months
The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below: * Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour. * Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas. * Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium.
1 secondary outcome
The difference in the complication rate between the two study arms
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
Zaid Zoumot, MBBS, MRCP, MSc study director
Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust
Pallav L Shah, MD, FRCP principal investigator
Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial ultrasound guided lymph node sampling in people with Mediastinal Lymphadenopathy and Hilar Lymphadenopathy, run by Royal Brompton & Harefield NHS Foundation Trust at 3 sites in 2 countries.
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: withdrawn, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Germany. 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 was withdrawn before enrolling participants, so there are no results.
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 percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms. (time frame: 18 months). 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 13 Jul 2016.