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Hd-bronchoscopy, Comparison to Standard White Light and Autofluorescence Bronchoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01676012
First received: August 15, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

Through technological improvement a new technique has become available in the form of high-definition (HD-) bronchoscopy. Current normal video white light bronchoscopy is the standard, and video-autofluorescence bronchoscopy (AFB) is offered by specialized centers only. The impact of this development with high-definition videobronchoscopy using a 1.1 megapixel chip on the diagnostic performance of bronchoscopy is however unknown.

The aim of the present study therefore is to explore the diagnostic performance (sensitivity and specificity) of HD-videobronchoscopy, HD + surface enhancement (iScan filtering technique) and HD + tone enhancement filtering in comparison to standard WLB and dual mode SAFE3000 autofluorescence videobronchoscopy in a high risk population.


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: High Definition Bronchoscopy; an Exploratory Study of Diagnostic Value in Comparison to Standard White Light Bronchoscopy and Autofluorescence Bronchoscopy

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • sensitivity [ Time Frame: one year ] [ Designated as safety issue: No ]
    Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.


Secondary Outcome Measures:
  • sensitivity and specificity of HD videobronchoscopy [ Time Frame: one year ] [ Designated as safety issue: No ]
    When the sensitivity and specificity of HD videobronchoscopy in either mode in the abovementioned study is in the vicinity of the reported sensitivity and specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this study perform a power analysis. With this information it may then be possible to design a new future study to compare sensitivity for detecting premalignant lesions in a high risk population in a prospective study.


Enrollment: 29
Study Start Date: September 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
five types of bronchoscopy

Bronchoscopy will be performed in a standardized order using five different imaging modes.

  1. Standard white light videobronchoscopy (WLB)
  2. High Definition -Bronchoscopy
  3. HD-bronchoscopy + surface enhancement (iScan-surface)
  4. HD-bronchoscopy + tone enhancement (iScan-tone)
  5. Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with suspected or proven head and neck or lung cancer fit for surgery and scheduled for diagnostic or therapeutic surgical procedure in the Radboud University Medical Center Nijmegen

Criteria

Inclusion Criteria:

  • Patients fit for surgery and scheduled for diagnostic or therapeutic surgical procedure under general anesthesia by the cardiothoracic or thoracic surgeon or ENT surgeon with suspected or proven lung cancer or head and neck cancer.
  • ASA physical status 1-3.
  • Age 18 years or older.
  • informed consent

Exclusion Criteria:

Contraindications are all known contraindications for diagnostic bronchoscopy such as:

  • bleeding disorders,
  • indication for use of anticoagulant therapy (acenocoumarol, warfarins, therapeutic dose of low molecular weight heparins or clopidogrel),
  • known allergy for lidocaine,
  • known pulmonary hypertension,
  • recent and/or uncontrolled cardiac disease. Presence of contraindications for the use of laryngeal mask (anatomical abnormalities) increased risk for intubation (mallampati score 4), or compromised upper airway due to extension of primary head and neck cancer.

ASA classification greater than or equal to 4.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01676012

Locations
Netherlands
Radboud University Medical Center Nijmegen
Nijmegen, Geert Grooteplein 10, Netherlands, 6525 GA
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: HFM vanderHeijden, MD principal investigator
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01676012     History of Changes
Other Study ID Numbers: 38719
Study First Received: August 15, 2012
Last Updated: October 20, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on November 23, 2014