Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling

Not Applicable

• Conditions: Lung Cancer,; Lymphomas,; Mediastinal Tumors,; Sarcoidosis,
• Interventions: Procedure: virtual bronchoscopy guided transbronchial needle aspiration; Procedure: endobronchial ultrasound guided transbronchial needle aspiration

• Registration Number: NCT01784185
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-13
• Primary Completion: 2014-02
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
virtual bronchoscopy guided transbronchial needle aspiration	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
virtual bronchoscopy guided transbronchial needle aspiration	endobronchial ultrasound 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

Primary Outcome Measures

Name	Time	Method
Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA	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

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw; 🇵🇱 Warsaw, Poland