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Completed

NCT Number: NCT02592837

EBUS-TBNA vs Flex 19G EBUS-TBNA

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for EBUS-TBNA as part of clinical care
  • Lymph nodes larger than 10mm in diameter
  • Age > 18 years
  • Written informed consent

Exclusion criteria

  • Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
  • Inability to obtain informed consent

Treatment and study plan

Flexible 19G EBUS-TBNA needle

Device

21G EBUS-TBNA needle

Device

Primary outcomes

  1. 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.

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 week

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

    Time frame: 1 month

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

    Time frame: 1 week

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

    Time frame: 1 week

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

    Time frame: 1 week

    Sensitivity = True Positives/(True Positives + False Negatives)

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

    Time frame: 1 week

    Sensitivity = True Positives/(True Positives + False Negatives)

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Collaborators

  • Olympus Corporation

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2015
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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