Lung Cancer, Clinical Trial
— VB/EBUS-TBNAOfficial title:
Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | April 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Poland | Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw | Warsaw |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Warsaw | Warsaw University of Technology |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of patients with local complications of VB-TBNA | Number of patients in whom large mediastinal vessels would be injured when performing VB-TBNA will be compared with respective number of patients with EBUS-TBNA associated large vessel injury. | During VB-TBNA and EBUS-TBNA procedure | Yes |
| Primary | 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 | No |
| Secondary | 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 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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