No registrations found.
ID
Source
Brief title
Health condition
- All adult patients with a suspected malignant mucosal lesion of the upper aerodigestive tract
- Patients with benign upper aerodigestive tract lesions
Sponsors and support
The Netherlands, provides an unrestricted educational grant.
Intervention
Outcome measures
Primary outcome
- Correlation between WLI and / or
NBI with histopathological diagnosis.
- Accuracy: percentage of true results = (true positives + true negatives)/ total results.
Secondary outcome
there are 6 different substudies. Every study has its own secondary outcomes. 4 secondary goals are:
1. To identify NBI + WLI as superior to WLI alone in the early detection of local HNC
recurrences after first line treatment
2. To identify NBI + WLI as a better diagnostic and staging tool in the determination of
tumor field and as a consequence tumor staging than WLI alone
3. To conclude that inter-observer and intra-observer variability/reliability in the visual
analysis of benign and (pre) malignant lesions in the upper aerodigestive tract is
higher using NBI+WLI than WLI alone.
4. To increase reliability and decrease inter-/intra-observer variability by creating a NBIatlas which will be helpful in correct interpretation of NBI and can be used as a
standard reference in ENT/head and neck oncology in order to increase earlier
detection of (pre)malignant HNC lesions using NBI
Background summary
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.
Study objective
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.
Study design
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.
Intervention
Observational cohort study, partially randomized controlled sub-studies.
The intervention itself is not part of the study.
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
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
Inclusion criteria
- 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
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6052 |
| NTR-old | NTR6199 |
| Other | NL5315204215 : METC 2015/152 |