Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling
VB/EBUS-TBNA
Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started Jan 2013
Shorter than P25 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 24, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJanuary 13, 2014
January 1, 2014
1.1 years
January 24, 2013
January 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Diagnostic accuracy of VB-TBNA vs. EBUS-TBNA - the number (and percentage) of cytologic specimens containing diagnostic material (neoplastic cells, granulomas)
up to 8 months
Other Outcomes (1)
Number of patients with local complications of VB-TBNA
During VB-TBNA and EBUS-TBNA procedure
Study Arms (1)
virtual bronchoscopy guided transbronchial needle aspiration
EXPERIMENTALvirtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA)(experimental method) and EBUS-TBNA (reference method) are performed in the same diagnostic session
Interventions
endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age below 18 years
- known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Warsawlead
- Warsaw University of Technologycollaborator
Study Sites (1)
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Warsaw, 02-097, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 24, 2013
First Posted
February 5, 2013
Study Start
January 1, 2013
Primary Completion
February 1, 2014
Study Completion
April 1, 2014
Last Updated
January 13, 2014
Record last verified: 2014-01