Clinical trial · Interventional
EBUS-TBNA Versus EBUS-TBNB
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) 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
Why stopped (as posted): Manufacturer did not develop and deliver the necessary biopsy forceps needles in time
Summary
Brief summary (as posted)
A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB). The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endobronchial ultrasound guided lymph node sampling | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EBUS-TBNA
- description
- Sampling using endobronchial ultrasound guided transbronchial needle aspiration
- interventionNames
- Device: Endobronchial ultrasound guided lymph node sampling
- type
- EXPERIMENTAL
- label
- EBUS-TBNB
- description
- Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.
- interventionNames
- Device: Endobronchial ultrasound guided lymph node sampling
Primary outcomes (1)
- measure
- The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
- 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 * Able to provide written informed consent Exclusion Criteria: * Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia) * Inability to obtain informed consent
References
Publications (0)
Data not yet available