Clinical trial NCT01784185: Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer,
Mediastinal Tumors,
Lymphomas,
Sarcoidosis,
Keywords: EBUS guided transbronchial needle aspiration (EBUS-TBNA)
virtual bronchoscopy (VB)
VB guided transbronchial needle aspiration VB-TBNA)
mediastinal sampling
transbronchial needle aspiration (TBNA)
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Warsaw University of Technology
First posted: 2013-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA
timeFrame: Approximately five days after the procedure, when the results of the cytological examination will be available
Secondary outcomes:
measure: Diagnostic accuracy of VB-TBNA vs. EBUS-TBNA - the number (and percentage) of cytologic specimens containing diagnostic material (neoplastic cells, granulomas)
timeFrame: up to 8 months
Other outcomes:
measure: Number of patients with local complications of VB-TBNA
timeFrame: During VB-TBNA and EBUS-TBNA procedure
Locations:
city: Warsaw
country: Poland
facility: Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Study officials:
References: