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

January 10, 2014 updated by: Rafał Krenke, Medical University of Warsaw

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 02-097
        • Recruiting
        • Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
        • Contact:
        • Principal Investigator:
          • Rafal Krenke, MD, PhD
        • Principal Investigator:
          • Piotr Korczynski, MD, PhD
        • Sub-Investigator:
          • Renata Langfort, MD, PhD
        • Sub-Investigator:
          • Joanna Domagala-Kulawik, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: virtual bronchoscopy guided transbronchial needle aspiration
Other Names:
  • VB-TBNA
Procedure: endobronchial ultrasound guided transbronchial needle aspiration
endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions
Other Names:
  • EBUS-TBNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA
Time Frame: 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
Approximately five days after the procedure, when the results of the cytological examination will be available

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of VB-TBNA vs. EBUS-TBNA - the number (and percentage) of cytologic specimens containing diagnostic material (neoplastic cells, granulomas)
Time Frame: 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.
up to 8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with local complications of VB-TBNA
Time Frame: During VB-TBNA and EBUS-TBNA procedure
Number of patients in whom large mediastinal vessels would be injured when performing VB-TBNA will be compared with respective number of patients with EBUS-TBNA associated large vessel injury.
During VB-TBNA and EBUS-TBNA procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Warsaw University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

January 24, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPU-DIMPA-WUM12(1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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