Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling (VB/EBUS-TBNA)
Recruitment status was: Recruiting
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.
|Lung Cancer, Mediastinal Tumors, Lymphomas, Sarcoidosis,||Procedure: virtual bronchoscopy guided transbronchial needle aspiration Procedure: endobronchial ultrasound guided transbronchial needle aspiration|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.|
- Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA [ Time Frame: Approximately five days after the procedure, when the results of the cytological examination will be available ]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
- Diagnostic accuracy of VB-TBNA vs. EBUS-TBNA - the number (and percentage) of cytologic specimens containing diagnostic material (neoplastic cells, granulomas) [ Time Frame: up to 8 months ]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.
- Number of patients with local complications of VB-TBNA [ Time Frame: During VB-TBNA and EBUS-TBNA procedure ]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.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: virtual bronchoscopy guided transbronchial needle aspiration
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
Other Name: VB-TBNAProcedure: endobronchial ultrasound guided transbronchial needle aspiration
endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions
Other Name: EBUS-TBNA
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784185
|Contact: Rafal Krenke, MD, PhDfirstname.lastname@example.org|
|Contact: Piotr Korczynski, MD, PhDemail@example.com|
|Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw||Recruiting|
|Warsaw, Poland, 02-097|
|Contact: Rafal Krenke, MD, PhD +48225992562 firstname.lastname@example.org|
|Principal Investigator: Rafal Krenke, MD, PhD|
|Principal Investigator: Piotr Korczynski, MD, PhD|
|Sub-Investigator: Renata Langfort, MD, PhD|
|Sub-Investigator: Joanna Domagala-Kulawik, MD, PhD|