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

Medical University of Warsaw

Status: Unknown

Conditions: Lung Cancer,; Sarcoidosis,; Mediastinal Tumors,; Lymphomas,

Treatments: Procedure: endobronchial ultrasound guided transbronchial needle aspiration; Procedure: virtual bronchoscopy guided transbronchial needle aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT01784185

IPU-DIMPA-WUM12(1)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 1 patient group

virtual bronchoscopy guided transbronchial needle aspiration

Experimental group

Description:

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

Treatment:

Procedure: virtual bronchoscopy guided transbronchial needle aspiration

Procedure: endobronchial ultrasound guided transbronchial needle aspiration