Clinical trial · Observational
Hd-bronchoscopy, Comparison to Standard White Light and Autofluorescence Bronchoscopy
High Definition Bronchoscopy; an Exploratory Study of Diagnostic Value in Comparison to Standard White Light Bronchoscopy and Autofluorescence Bronchoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- five types of bronchoscopy
- description
- 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
Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
- one year
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available