Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.

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

Sponsors

Lead sponsor: Medical University of Warsaw

Collaborator: Warsaw University of Technology

Source 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.

Overall Status Unknown status
Start Date January 2013
Completion Date April 2014
Primary Completion Date February 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
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
Enrollment 60
Condition
Intervention

Intervention type: Procedure

Intervention name: virtual bronchoscopy guided transbronchial needle aspiration

Arm group label: virtual bronchoscopy guided transbronchial needle aspiration

Other name: VB-TBNA

Intervention type: Procedure

Intervention name: endobronchial ultrasound guided transbronchial needle aspiration

Description: endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions

Arm group label: virtual bronchoscopy guided transbronchial needle aspiration

Other name: EBUS-TBNA

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Rafal Krenke, MD, PhD

Phone: +48225992562

Email: [email protected]

Location
facility status contact investigator
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw Recruiting Rafal Krenke, MD, PhD +48225992562 [email protected] Rafal Krenke, MD, PhD Principal Investigator Piotr Korczynski, MD, PhD Principal Investigator Renata Langfort, MD, PhD Sub-Investigator Joanna Domagala-Kulawik, MD, PhD Sub-Investigator
Location Countries

Poland

Verification Date

January 2014

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Medical University of Warsaw

Investigator full name: Rafał Krenke

Investigator title: MD, PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: virtual bronchoscopy guided transbronchial needle aspiration

Arm group type: Experimental

Description: virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA)(experimental method) and EBUS-TBNA (reference method) are performed in the same diagnostic session

Acronym VB/EBUS-TBNA
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: Single (Investigator)

Source: ClinicalTrials.gov