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High Definition bronchoscopy, an exploratory study of diagnostic value in comparison to standard white light bronchoscopy and autofluorescence bronchoscopy

High Definition bronchoscopy, an exploratory study of diagnostic value in comparison to standard white light bronchoscopy and autofluorescence bronchoscopy - HD bronchoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35123
Enrollment
50
Registered
2012-05-10
Start date
2013-03-11
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck cancer lung cancer

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 ENT malignancy. -ASA physical status 1-3. -Age 18 years or older.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

MeasureTime frame
when differences are established between the different bronchcopy modes a power analysis may be performed to determine the feasibility of a prospectively designed study to investigate the diagnostic performance.

Primary

MeasureTime frame
Decriptive study of diagnostic performance of HD-bronchoscopy using different imaging techniques in comparison to standard white light bronchoscopy and autofluorescence bronchoscopy in determining epithelial changes, changes in vascularity and tumour margins.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)