Hd-bronchoscopy, Comparison to Standard White Light and Autofluorescence Bronchoscopy
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|ClinicalTrials.gov Identifier: NCT01676012|
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
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 or disease|
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|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||High Definition Bronchoscopy; an Exploratory Study of Diagnostic Value in Comparison to Standard White Light Bronchoscopy and Autofluorescence Bronchoscopy|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
five types of bronchoscopy
Bronchoscopy will be performed in a standardized order using five different imaging modes.
- Sensitivity [ Time Frame: one year ]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. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). 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.
- Sensitivity and Specificity of HD Videobronchoscopy [ Time Frame: one year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676012
|Radboud University Medical Center Nijmegen|
|Nijmegen, Geert Grooteplein 10, Netherlands, 6525 GA|
|Principal Investigator:||HFM vanderHeijden, MD||Principal Investigator|