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 Lymph-adenopathy: 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)
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
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
- 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
- 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
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: 1. Scheduled for EBUS-TBNA as part of clinical care 2. Lymph nodes larger than 10mm in diameter 3. Age \> 18 years 4. written informed consent Exclusion Criteria: 1. Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia) 2. Inability to obtain informed consent
References
Publications (0)
Data not yet available