Clinical trial · Interventional
Effect of Needle Size in Diagnostic Yield of EBUS-TBNA in Sarcoidosis and Lymphoma
Prospective Trial Comparing the Diagnostic Yield of Two Different Needle Sizes Used in EBUS-TBNA for Sarcoidosis and Lymphoma
- 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)
The guided FNA by endobronchial ultrasound ( Endobronchial Ultrasound guided transbronchial Needle Aspiration or EBUS-TBNA) is a minimally invasive technique with an established role in the staging of lung cancer 1, and in the evaluation of intrathoracic lymph node metastases from extrathoracic primary cancer2 . There is also a role in cases of isolated hilar and mediastinal lymph nodes in which the differential diagnosis includes mostly sarcoidosis, lymphoma and tuberculosis. 3 Various studies have evaluated more recently the diagnostic yield of EBUS-TBNA specifically for sarcoidosis 4 and thoracic lymphoma 5-6. Although there is emerging data supporting the usefulness of EBUS-TBNA in the investigation of these two pathologies, the efficacy results vary according to the target populations and certain parameters. Moreover, although a large randomized study demonstrated e superiority of EBUS-TBNA over conventional bronchoscopic sampling methods \[ bronchoalveolar lavage (BAL) and trans-bronchial biopsies (TBB \] for the diagnosis of sarcoidosis , 7 the results suggest that there is still room for optimizing the performance of EBUS-TBNA \[b\] . In the field of lymphoma, obtaining large enough specimens for adequate subtyping also remains a concern. 8 In order to improve the performance of EBUS -TBNA , new needles have been developed with the aim to provide biopsies for histological evaluation rather than purely cytological. The ViziShot FLEX © (Olympus) 19 gauge needle (19 gauge or 19G) is a large needle, which can provide both tissue and needle aspiration , and has the advantage of being more flexible. For this study, the investigators want to compare the diagnostic yield of EBUS-TBNA using needle ViziShot FLEX 19G (1.11 mm) with that of the standard 22G needle ( NA-201SX; Olympus) , in the investigation of hilar or mediastinal lymphadenopathy suspected to be sarcoidosis or lymphoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenopathy Hilar | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoidosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vizishot 22G needle (standard) | Device | — | UNRESOLVED |
| ViziShot FLEX 19G needle | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vizishot Flexneedle 19G
- description
- Mediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle
- interventionNames
- Device: ViziShot FLEX 19G needle
- type
- ACTIVE_COMPARATOR
- label
- Vizishot 22G
- description
- Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle
- interventionNames
- Device: Vizishot 22G needle (standard)
Primary outcomes (1)
- measure
- Diagnostic yield of EBUS-TBNA
- timeFrame
- 12 months after enrollment of the last patient.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Patient t referred for specimens by EBUS -TBNA with clinical and radiological suspicion of sarcoidosis or lymphoma , with pathological lymph node on imaging (small diameter ≥ 1.0 cm CT-scan or hyper metabolism with PET scan) in para-tracheal stations, sub-carinal and / or hilar (stations 2, 4, 7, 10, 11 and 12), right and / or left. * Lymph nodes with a small diameter of at least 0.5 cm in CT-scan or PET / CT scan performed in the previous 4-6 weeks. * Patient investigated in the setting of either an initial diagnosis or a suspicion of lymphoma recurrence (post-treatment). * Patient able to consent to the procedure and to authorize us by written proxy, included in the consent form for the study, to obtain a copy of the subsequent results or radiological (PET, CT-scan, chest X-ray) or histopathological (linked with age sampled of intrathoracic lymph nodes). * Patient deemed fit to tolerate the procedure. Exclusion criteria * Patient unable to give consent. * Female patient during pregnancy * Patient aged under 18. * Patient with significant coagulopathy ( INR \> 1.5 ; platelet count\<50 000 / mm 3 ). * Patient anticoagulated (oral or parenteral) and whose anticoagulation can not be suspended for the procedure. * Obvious involvement of organ (s) with the possibility of confirming granulomas or suspicious cells of lymphoma by means of a procedure considered less invasive (.. e g, lymph node biopsy of cervical, supraclavicular or inguinal nodes; skin biopsy).
References
Publications (0)
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