N/A
N=32
Hd-bronchoscopy, Comparison to Standard White Light and Autofluorescence Bronchoscopy
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01676012 ↗Enrolled (actual)
32
Serious AEs
6.9%
Results posted
May 2015
Primary outcome: Primary: Sensitivity — 0.28; 0.72; 0.78; 1.33 # vascular sites detected per patient
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Radboud University Medical Center
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity |
0.28; 0.72; 0.78; 1.33; 0.12 | — |
| SECONDARY Sensitivity and Specificity of HD Videobronchoscopy |
— | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01676012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.