Trial record 6 of 8 for:    Open Studies | "Mediastinal Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of Warsaw
Sponsor:
Collaborator:
Warsaw University of Technology
Information provided by (Responsible Party):
Rafał Krenke, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01784185
First received: January 24, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Lung Cancer,
Mediastinal Tumors,
Lymphomas,
Sarcoidosis,
Procedure: virtual bronchoscopy guided transbronchial needle aspiration
Procedure: endobronchial ultrasound guided transbronchial needle aspiration

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Number of patients with local complications of VB-TBNA [ Time Frame: During VB-TBNA and EBUS-TBNA procedure ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: VB-TBNA
Procedure: endobronchial ultrasound guided transbronchial needle aspiration
endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions
Other Name: EBUS-TBNA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784185

Contacts
Contact: Rafal Krenke, MD, PhD +48225992562 rafalkrenke@interia.pl
Contact: Piotr Korczynski, MD, PhD +48225992562 drkorczynski@gmail.com

Locations
Poland
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw Recruiting
Warsaw, Poland, 02-097
Contact: Rafal Krenke, MD, PhD    +48225992562    rafalkrenke@interia.pl   
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         
Sponsors and Collaborators
Medical University of Warsaw
Warsaw University of Technology
  More Information

No publications provided

Responsible Party: Rafał Krenke, MD, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01784185     History of Changes
Other Study ID Numbers: IPU-DIMPA-WUM12(1)
Study First Received: January 24, 2013
Last Updated: January 10, 2014
Health Authority: Poland: Bioethics Appeals Commission

Keywords provided by Medical University of Warsaw:
EBUS guided transbronchial needle aspiration (EBUS-TBNA)
virtual bronchoscopy (VB)
VB guided transbronchial needle aspiration VB-TBNA)
mediastinal sampling
transbronchial needle aspiration (TBNA)

Additional relevant MeSH terms:
Mediastinal Neoplasms
Sarcoidosis
Lymphatic Diseases
Lymphoproliferative Disorders
Mediastinal Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Thoracic Diseases
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014