Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling

Study Overview
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Brief Summary
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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.

Official Title
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Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.

Conditions
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Lung Cancer,, Mediastinal Tumors,, Lymphomas,, Sarcoidosis,

Intervention / Treatment
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* Procedure: virtual bronchoscopy guided transbronchial needle aspiration
* Procedure: endobronchial ultrasound guided transbronchial needle aspiration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual bronchoscopy guided transbronchial needle aspiration<br>virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA)(experimental method) and EBUS-TBNA (reference method) are performed in the same diagnostic session | Procedure: virtual bronchoscopy guided transbronchial needle aspiration<br> <br> * Other names: VB-TBNA;Procedure: endobronchial ultrasound guided transbronchial needle aspiration<br>* endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions<br>* Other names: EBUS-TBNA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA | 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 | Approximately five days after the procedure, when the results of the cytological examination will be available | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of VB-TBNA vs. EBUS-TBNA - the number (and percentage) of cytologic specimens containing diagnostic material (neoplastic cells, granulomas) | Comparison of the diagnostic accuracy of VB-TBNA vs. EBUS-TBNA (in terms of number of cytologic specimens containing diagnostic material e.g. neoplastic cells, granulomas) in patients with mediastinal mass or mediastinal lymph node enlargement. Also the number of patients in whom the specific diagnosis could be established by VB-TBNA vs EBUS-TBNA. | up to 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual bronchoscopy (VB), EBUS guided transbronchial needle aspiration (EBUS-TBNA), VB guided transbronchial needle aspiration VB-TBNA), mediastinal sampling, transbronchial needle aspiration (TBNA)