Clinical trial · Interventional
EBUS-TBNA vs Flex 19G EBUS-TBNA
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphadenopathy | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoidosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 21G EBUS-TBNA needle | Device | — | UNRESOLVED |
| Flexible 19G EBUS-TBNA needle | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flex 19G EBUS-TBNA
- description
- Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle
- interventionNames
- Device: Flexible 19G EBUS-TBNA needle
- type
- ACTIVE_COMPARATOR
- label
- EBUS-TBNA
- description
- Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle
- interventionNames
- Device: 21G EBUS-TBNA needle
Primary outcomes (1)
- measure
- The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available