Clinical trial NCT02592837: EBUS-TBNA vs Flex 19G EBUS-TBNA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphadenopathy
Lung Cancer
Sarcoidosis
Lymphoma
Keywords: Endobronchial ultrasound
EBUS
TBNA
Mediastinal ymphadenopathy
Hilar lymphadenopathy
Lung cancer
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Olympus Corporation
First posted: 2015-10-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
timeFrame: 1 week
Secondary outcomes:
measure: 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.
timeFrame: 1 week
measure: The difference in complication rates between the two study arms
timeFrame: 1 month
measure: The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis
timeFrame: 1 week
measure: The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma
timeFrame: 1 week
measure: The difference in sensitivity for detecting sarcoidosis between the two study arms
timeFrame: 1 week
measure: The difference in sensitivity for detecting lymphoma between the two study arms
timeFrame: 1 week
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundation Trust
name: Pallav L Shah, MBBS MD
role: PRINCIPAL_INVESTIGATOR
References: