to establish the diagnostic and prognostic value of Narrow band Imaging (NBI) in head and neck cancer
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective: to validate NBI (using flexible and rigid laryngosopes) in
HNC as a prognosticator and establish NBI as a reliable diagnostic tool by
discriminating (pre)malignant lesions from benign lesions
Secondary outcome
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 consquence 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 NBI-atlas which will be helpful in correct interpretation of NBI.
Background summary
Narrow Band Imaging (NBI) is a relatively new imaging technique used in
endoscopy and increases the diagnostic potential of conventional white light
imaging (WLI) endoscopy by highlighting abnormalities in the superficial
vasculature of mucosal lesions. Detection, diagnosis, staging, treatment
outcome and prognosis of patients with a malignancy of the upper aerodigestive
tract might improve when Narrow Band Imaging in combination with standard
(White Light) endoscopy is used.
Study objective
to establish the diagnostic and prognostic value of Narrow band Imaging (NBI)
in head and neck cancer
Study design
Observational cohort study, partially randomized controlled.
There are 6 sub-studies:
Study 1: comparison of flexible transnasal laryngoscopy with rigid
microlaryngoscopy using WLI and WLI+NBI in diagnosis of both benign and
malignant lesions
Study 2: radical resection rate of laser excision and recurrence free survival
after laser excision using WLI or WLI+NBI
Study 3: descriptive study to determine accuracy of WLI and WLI+NBI in
detecting normal and (pre)malignant mucosa
Study 4: detection of recurrences after RT using WLI or WLI+NBI during flexible
transnasal laryngoscopy
Study 5: detection of recurrences after RT using WLI or WLI+NBI during rigid
microlaryngoscopy under general anaesthesia
Study 6: descriptive study to determine accuracy of WLI and WLI+NBI in
discriminating malignant tissue from non-malignant irradiated mucosa
Study burden and risks
Burdens: although standard diagnostic procedures are followed during follow-up
of the included patients, the use of NBI besides WLI could lead to additional
transnasal flexible laryngoscopies because the clinician is triggered to
possible mucosal abnormalities when using NBI. This is also the case nowadays
when additional flexible videolaryngoscopy is performed when the visualization
is inconclusive after flexible laryngoscopy with routinely used fiberscopes .
Risks: no additional risks are to be expected, since standard diagnostic,
staging, treatment and follow-up procedures are maintained. Flexible
laryngosopies are safe and additional biopsies without significant risks.
Benefits:visualization will be done using distal chip videolaryngoscopes which
have a better visualization than routinely used fiberscopes. An earlier and
better detection of a primary tumor or recurrent disease can be expected.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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 |
|---|---|
| CCMO | NL53152.042.15 |