Detection, diagnosis, staging, treatment outcome and prognosis of patients with a malignancy of the upper aerodigestive tract improve when Narrow Band Imaging in combination with standard (White Light) endoscopy is used.
ID
Bron
Verkorte titel
Aandoening
- All adult patients with a suspected malignant mucosal lesion of the upper aerodigestive tract
- Patients with benign upper aerodigestive tract lesions
Ondersteuning
The Netherlands, provides an unrestricted educational grant.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Correlation between WLI and / or
NBI with histopathological diagnosis. <br>
- Accuracy: percentage of true results = (true positives + true negatives)/ total results.
Achtergrond van het onderzoek
Visualization by (flexible) endoscopy of the mucosa of oral cavity, nasal cavity, pharynx and larynx is the hallmark in detection and diagnosis of mucosal benign and malignant lesions of the upper aerodigestive tract. Technical improvements resulted in distal chip endoscopes with digital image processing making blood vessels more visible using a technique called Narrow Band Imaging (NBI). NBI is a relatively new imaging technique (developed by Olympus Corporation, Tokyo, Japan) which increases the diagnostic potential of conventional white light imaging (WLI) endoscopy. NBI highlights abnormalities in the superficial vasculature of mucosal lesions by using narrow-bandwidth filters in a sequential red-greenblue illumination system. Although in other fields of medicine NBI has confirmed itself as an important diagnostic and prognostic instrument, in otorhinolaryngology and head and neck oncology, it has not yet been evaluated as an important reliable diagnostic or prognostic tool. We believe NBI should be used as a standard tool in diagnosis and treatment of patients with a (suspected) malignancy of the upper aero-digestive tract, but only after establishing its diagnostic and prognostic value in a large cohort of patients. Therefore, we planned to establish the role of NBI in improving diagnosis, clinical outcome and prognosis in head and neck cancer in six different substudies.
Doel van het onderzoek
Detection, diagnosis, staging, treatment outcome and prognosis of patients with a malignancy of the upper aerodigestive tract improve when Narrow Band Imaging in combination with standard (White Light) endoscopy is used.
Onderzoeksopzet
1. when patients arive in the outpatient clinic with complaints for the first time
2. during surgery
3. follow up: every 3-6 months, depending on diagnosis.
Onderzoeksproduct en/of interventie
Observational cohort study, partially randomized controlled sub-studies.
The intervention itself is not part of the study.
Publiek
M.A. Zwakenberg
Department of Otorhinolaryngology/Head and Neck Surgery, University Medical Center Groningen - HPC BB20
Groningen 9700 RB
The Netherlands
050 3612540
m.a.zwakenberg@umcg.nl
Wetenschappelijk
M.A. Zwakenberg
Department of Otorhinolaryngology/Head and Neck Surgery, University Medical Center Groningen - HPC BB20
Groningen 9700 RB
The Netherlands
050 3612540
m.a.zwakenberg@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- suspicion of or proven carcinoma of the oral cavity, nasal cavity, pharynx or larynx.
- suspicion of a benign lesion of the larynx
- > 18 yrs of age
- informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
none
Opzet
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Register | ID |
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NTR-new | NL6052 |
NTR-old | NTR6199 |
Ander register | NL5315204215 : METC 2015/152 |