High Definition bronchoscopy, an exploratory study of diagnostic value in comparison to standard white light bronchoscopy and autofluorescence bronchoscopy
- Conditions
- 10038737lung cancerhead and neck cancer1003866610029107
- Registration Number
- NL-OMON35123
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 29
-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 ENT malignancy.
-ASA physical status 1-3.
-Age 18 years or older.
Contraindications are all known contraindications for diagnostic bronchoscopy such as:
- bleeding disorders,
- indication for use of anticoagulant therapy (acenocoumarol, warfarine, therapeutic dose of low molecular weight heparines or clopidrogel),
- 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 (malampatti score 4),
ASA classification greater than or equal to 4.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Decriptive study of diagnostic performance of HD-bronchoscopy using different<br /><br>imaging techniques in comparison to standard white light bronchoscopy and<br /><br>autofluorescence bronchoscopy in determining epithelial changes, changes in<br /><br>vascularity and tumour margins.</p><br>
- Secondary Outcome Measures
Name Time Method <p>when differences are established between the different bronchcopy modes a power<br /><br>analysis may be performed to determine the feasibility of a prospectively<br /><br>designed study to investigate the diagnostic performance.</p><br>