Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.
18 Years
N/A
Both
Lung Cancer,, Mediastinal Tumors,, Lymphomas,, Sarcoidosis,
Trial Information
Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Outcome Measure:
Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA
Outcome 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
Outcome Time Frame:
Approximately five days after the procedure, when the results of the cytological examination will be available
Safety Issue:
No
Authority:
Poland: Bioethics Appeals Commission
Study ID:
IPU-DIMPA-WUM12(1)
NCT ID:
NCT01784185
Start Date:
January 2013
Completion Date:
September 2013
Related Keywords:
- Lung Cancer,
- Mediastinal Tumors,
- Lymphomas,
- Sarcoidosis,
- EBUS guided transbronchial needle aspiration (EBUS-TBNA)
- virtual bronchoscopy (VB)
- VB guided transbronchial needle aspiration VB-TBNA)
- mediastinal sampling
- transbronchial needle aspiration (TBNA)
- Lung Neoplasms
- Lymphoma
- Mediastinal Neoplasms
- Sarcoidosis
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