LymphadenopathyNCT02916459
EBUS-TBNA vs Flex 19G EBUS-TBNA
A study testing 21G EBUS-TBNA needle and Flexible 19G EBUS-TBNA needle in people with Lymphadenopathy and Lung Cancer, run by Heidelberg University at 1 site in Germany.
Trial summary
This is a prospective randomised diagnostic clinical study to determine whether the use of a new flexible sampling needle can improve the yield of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA). 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?
- 21G EBUS-TBNA needle and Flexible 19G 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 siteGermany
- Study dates
- Oct 2016to Oct 2018
- 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.
Germany1 site, 1 recruiting
- Recruiting
Department of Pneumology and Critical Care medicine
Heidelberg, Baden-Wurttemberg, 69190
Felix JF Herth, MD, PhD, +49 6221 396 ext. 1200, felix.herth@thoraxklinik-heidelberg.de
Felix JF Herth, MD, Phd
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 Lymph-adenopathy: a Randomised Trial
This is a prospective randomised diagnostic clinical study to determine whether the use of a new flexible sampling needle can improve the yield of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical reasons as deemed necessary by the managing physician or multidisciplinary team will be randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be performed under local anaesthesia using conscious sedation or general anaesthesia according to usual practice at the trial centre. Specimens will be placed in saline and formalin and forwarded to the pathology laboratory. The specimens will be spun down to create a cell pellet which will undergo cytological and histological examination as per usual protocol at the trial centre.The pathologist, who will be blinded as to which technique was used to obtain the sample, will grade the quality, quantity, and cellularity of the specimens.
- Conditions
- Lymphadenopathy, Lung Cancer, Sarcoidosis, Lymphoma
- Being tested
- 21G EBUS-TBNA needle, Flexible 19G EBUS-TBNA needle
- 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.
21G EBUS-TBNA needleDevice
Flexible 19G EBUS-TBNA needleDevice
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNA | Active comparator | Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle Receives: Device: 21G EBUS-TBNA needle |
| 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 |
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 posted27 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Corporation
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916459
- Sponsor's protocol ID
- 19G 1.1-2016
- Status last verified
- Feb 2017
- First submitted
- 26 Sep 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. 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 Lymph-adenopathy: a Randomised Trial
- ClinicalTrials.gov ID
- NCT02916459
- Acronym / sponsor ID
- 19G 1.1-2016
- Conditions
- Lymphadenopathy, Lung Cancer, Sarcoidosis, Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Olympus Corporation
- Study start
- Oct 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 27 Sep 2016 (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.
This is a prospective randomised diagnostic clinical study to determine whether the use of a new flexible sampling needle can improve the yield of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical reasons as deemed necessary by the managing physician or multidisciplinary team will be randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be performed under local anaesthesia using conscious sedation or general anaesthesia according to usual practice at the trial centre. Specimens will be placed in saline and formalin and forwarded to the pathology laboratory. The specimens will be spun down to create a cell pellet which will undergo cytological and histological examination as per usual protocol at the trial centre.The pathologist, who will be blinded as to which technique was used to obtain the sample, will grade the quality, quantity, and cellularity of the specimens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA | Active comparator | Device: 21G EBUS-TBNA needleMediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle |
| Flex 19G EBUS-TBNA | Experimental | Device: Flexible 19G EBUS-TBNA needleMediastinal and hilar lymph node sampling using the flexible 19G 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 |
|---|---|---|
| 21G EBUS-TBNA needle | Device | EBUS-TBNA |
| Flexible 19G EBUS-TBNA needle | Device | Flex 19G 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 21G EBUS-TBNA needle and Flexible 19G EBUS-TBNA needle in people with Lymphadenopathy and Lung Cancer, run by Heidelberg University at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 7 Feb 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Herth, Prof. Dr. (+49-(0)6221-396-1201, herth@uni-heidelberg.de), or a site near the patient. 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 7 Feb 2017.