ClinicalTrials.gg
Status unknownNCT04200105Updated Dec 18, 2019

EBUS-TBNA vs Acquire TBNB

An interventional study of EBUS-TBNA and Acquire TBNB in Mediastinal Lymphadenopathy, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.

Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to determine whether a new type of needle used for sampling lymph nodes (glands) around the airways of the lung, during a procedure called an endobronchial ultrasound (EBUS, provides more or better quality tissue to allow a definite diagnosis to be made than with the current standard sampling needle. Two hundred and fifty patients will be randomised to procedures using either the new or standard needle, and the results compared.

Read the detailed description

The causes of mediastinal lymphadenopathy include infection, reactive lymphadenopathy, granulomatous disorders, and malignancy (metastases from various primaries, lymphoma, thymoma, neurogenic tumours). Radiological appearances are usually inadequate at providing a definitive diagnosis. In granulomatous disorders such as sarcoidosis as well as certain infections including tuberculosis, there is frequently mediastinal or hilar lymph node involvement without evidence of disease activity in other organs or lymph node groups. In malignancy, the metastatic involvement of lymph nodes has important prognostic significance. However, lymph node enlargement as seen on computerised tomography (CT) scanning is a poor predictor of disease involvement, and positron emission tomography (PET) of the mediastinum has a 10-15% false positive rate. Adequate mediastinal lymph node sampling is therefore essential in order to reach a definitive diagnosis and obtain satisfactory staging information.

Mediastinal nodal sampling has traditionally been performed using invasive surgical techniques which carry significant morbidity and mortality. These procedures (cervical mediastinoscopy, anterior mediastinotomy) require general anaesthesia and a hospital inpatient stay. Some patients with significant comorbidities are therefore not considered for these procedures as they are deemed unfit for anaesthesia. Safer, less invasive, and more cost-effective procedures using endoscopic ultrasonography to guide needle aspiration of mediastinal lymph nodes have been developed. Endobronchial ultrasound (EBUS) used to guide transbronchial needle aspiration (TBNA) of mediastinal masses has, in a matter of a few years, established itself firmly within the diagnostic and staging algorithm for lung cancer, and also in the diagnosis of other causes of mediastinal and hilar lymphadenopathy such as sarcoidosis and tuberculosis. A wide range of studies has demonstrated the effectiveness and safety of this technique, with various studies reporting sensitivities of between 67% and 92%3.

EBUS-guided needle aspirates performed with 22 gauge needles yield cytological specimens which are often inadequate at providing a firm diagnosis, or at confidently excluding other malignancies such as lymphoma. Immunohistochemistry and mutational analysis are today playing a more important role in the treatment of lung cancer. There is an increasing need for larger tissue samples and ideally biopsy material to enable advanced histopathological examination of specimens. For example, a substantial percentage of lung cancers express cell surface epidermal growth factor receptors (EGFRs). Small molecules designed to inhibit the tyrosine kinase (TK) domain of the EGFR, such as gefitinib and erlotinib, have demonstrated biologic and clinical responses in patients with mutations within the EGFR-TK domain. These TK inhibitors are now an important component of the armamentarium of the thoracic oncologist in the treatment of lung cancer. It has therefore become essential to establish the EGFR mutation status of lung cancers before consideration of treatment. Mutations of the KRAS gene in lung cancer patients have been shown to confer resistance to both erlotinib and gefitinib, adding to the importance of testing tissue samples for these mutations as well. In the past, tests for EGFR and KRAS gene mutations could only be performed on block tumours post resection, however advances in molecular biology in recent years have led to the ability to test small biopsy specimens for such mutations by polymerase chain reaction (PCR) analysis, fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). EBUS-TBNA, however, can only provide needle aspirates. These can provide samples adequate for cytological assessment, but do not always contain sufficient material to enable the formation of a cell block, thereby precluding histological assessment. Larger sized core tissue biopsy specimens are therefore likely to help in the histopathological assessment of lung cancer, and also in the diagnosis of sarcoidosis, lymphoma and other causes of mediastinal lymphadenopathy. This is likely to become even more important in the future as new clinically relevant genetic mutations are identified, and appropriate tests developed.

A novel transbronchial needle has been developed. This franseen needle has a crown tipped needle with three symmetrical cutting heels placed in a circumferential pattern designed with the intent to capture more tissue (figure 1). This needle tip was originally designed for use in interventional radiology, and is now the one of the leading designs used in endoscopic ultrasound of the gastrointestinal tract. This new needle can be passed down an EBUS scope and can hypothetically circumvent the deficiencies of EBUS-TBNA highlighted above by providing greater tissue volume for histological assessment and any subsequent molecular and genetic testing.

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Conditions studied

  • Mediastinal Lymphadenopathy
03

In context

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Scheduled for EBUS-TBNA as part of clinical care
  2. Lymph node size ≥5mm on CT scan
  3. Age > 18 years
  4. Written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia, other bleeding diathesis)
  2. Inability to obtain informed consent
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Active comparator
    EBUS TBNA

    Patients will undergo a standard EBUS examination, with sampling using a standard 22G EBUS needle.

    Device: EBUS-TBNA

  • Experimental
    Acquire TBNB

    Patients will undergo a standard EBUS examination, with sampling using an Acquire TBNB needle.

    Device: Acquire TBNB

Interventions

  • DeviceEBUS-TBNA

    Mediastinal and hilar lymph node sampling using a standard 22G EBUS needle

  • DeviceAcquire TBNB

    Mediastinal and hilar lymph node sampling using the Acquire TBNB needle

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What researchers measure

Primary outcomes

  1. The difference in cell volume of cancer or other diagnostic tissue obtained between the two study arms

    Time frame: 1 week

Secondary outcomes

  1. 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 month

  2. The difference between the two study arms in the amount of DNA obtained.

    Time frame: 1 month

  3. The difference in complication rates between the two study arms.

    Time frame: 1 month

  4. The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis.

    Time frame: 1 month

  5. The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma.

    Time frame: 1 month

  6. The difference in sensitivity for detecting sarcoidosis between the two study arms.

    Time frame: 1 month

  7. The difference in sensitivity for detecting lymphoma between the two study arms.

    Time frame: 1 month

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Study locations

1 site
  • Royal Brompton Hospital
    London, SW3 6NP, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2020; primary completion for Mar 2021, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2019
First posted
Dec 16, 2019
StartEst.
Mar 2, 2020
Primary completionEst.
Mar 1, 2021
CompletionEst.
Aug 1, 2021
Last update
Dec 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04200105
Responsible party
Sponsor
First posted
Dec 16, 2019
Start date
Mar 2, 2020 (estimated)
Primary completion
Mar 1, 2021 (estimated)
Completion
Aug 1, 2021 (estimated)
Last update
Dec 18, 2019

Study contacts

Samuel V Kemp, MBBS
Contact
s.kemp@rbht.nhs.uk
02073528121 ext. 88021
Sandra Guzaviciute
Contact
s.guzavicite@rbht.nhs.uk
02073528121 ext. 82744
Samuel V Kemp, MBBS
principal investigator · Royal Brompton and Harefield NHS FT

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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