Clinical trial · Interventional
Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling
Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.
- 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 study has been designed to evaluate the clinical application of the new virtual bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or enlarged lymph nodes. The software uses data from thorax CT scan and enables airway segmentation and reconstruction simultaneously with predefined mediastinal targets. The most suitable sites for transbronchial needle aspiration are displayed on the internal surface of the airways showed in VB mode. The diagnostic yield of the new system-assisted TBNA will be compared to the reference method (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods. Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA of the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained with the two methods will be assessed and compared.
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 |
| Lymphomas, | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mediastinal Tumors, | Mediastinal Neoplasm | ALIAS | 0.90 |
| Sarcoidosis, | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endobronchial ultrasound guided transbronchial needle aspiration | Procedure | — | UNRESOLVED |
| virtual bronchoscopy guided transbronchial needle aspiration | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- virtual bronchoscopy guided transbronchial needle aspiration
- description
- virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA)(experimental method) and EBUS-TBNA (reference method) are performed in the same diagnostic session
- interventionNames
- Procedure: virtual bronchoscopy guided transbronchial needle aspiration
- Procedure: endobronchial ultrasound guided transbronchial needle aspiration
Primary outcomes (1)
- measure
- Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA
- timeFrame
- Approximately five days after the procedure, when the results of the cytological examination will be available
- description
- Comparison of the quality and adequacy of the cytologic specimens (in terms of lymphocyte percentage, the presence of neoplastic cells and dust-laden macrophages) collected by VB-TBNA vs. EBUS-TBNA in patients with mediastinal mass or mediastinal lymph node enlargement
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * provided informed consent * mediastinal mass or lymph node enlargement that requires bronchoscopy and transbronchial sampling * quality of the CT scan which allows bronchial tree and mediastinal target segmentation and reconstruction Exclusion Criteria: * Age below 18 years * known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
References
Publications (0)
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