Optical techniques in diagnosis and management of premalignant and malignant laryngeal and pharyngeal lesions.

Major improvements have been made in flexible endoscopic tools for the
assessment of mucosal and submucosal lesions in the upper aerodigestive tract.
In the past decade several types of transnasal video endoscopes have been
developed that are being used increasingly in otorhinolaryngology. These
videolaryngoscopes show tremendous increase in visibility of detail compared to
the ordinary used transnasal fiberoptic laryngoscope. And in the laryngoscopes
with an instrument channel it is also possible to obtain tissue for
histopathologic investigation. However, due to lack of evidence on the accuracy
of these videolaryngoscopes, direct laryngoscopy under general anaesthesia has
remained the gold standard for determination of the extend of laryngeal and
pharyngeal lesions suspect for carcinoma and to perform biopsy.

In this study we will analyse the accuracy of new endoscopic methods in the
detection and determination of the extend of laryngeal and pharyngeal
epithelial lesions. If this method is proven accurate, direct laryngoscopy
under general anaesthesia may no longer be needed in the routine diagnostic
work-up. It will obviate the need for pre-operative consultation of
anaesthesiologists, the risks of general anaesthesia in patients with often
significant comorbidity and possible delays in treatment. More timely treatment
is likely to result in a reduction of duration of uncertainty and anxiety for
the patient. Lastly, it may decrease health care costs and improve outcome.

The endoscopes included in this study are all flexible transnasal
laryngoscopes. Each of them is CE marked and currently used in daily practice
in Radboud University Nijmegen Medical Centre. The fiberoptic laryngoscope,
videolaryngoscope with i-scan filter and high definition (HD) videolaryngoscope
with i-scan filter [Pentax, Japan] are included. A videolaryngoscope with a
working channel will not be used, therewithal strict disinfestations and
sterilization methods the risk of infection is negligible. I-scan is a
postprocessing digital image enhancement with adjustable tonal, contrast and
surface filters with the intent to increase visibility and differentiation of
pathologic mucosa. In gastroenterology a prospective randomized control trial
has shown significant higher detection of neoplastic lesions and more flat
benign tumours when using a HD colonoscope with i-scan function compared to
standard video colonoscopy [Hoffman et al, 2010].

Primary objective is to analyse whether transnasal videolaryngoscopy in
outpatient practice is more accurate in determination of the extend of the
affected mucosa of laryngopharyngeal tumours compared to direct laryngoscopy
under general anaesthesia; the current gold standard.

Secondary objectives are multiple:
• To study whether transnasal videolaryngoscopy in outpatient practice is more
accurate in determination of the extend of the affected mucosa of
laryngopharyngeal tumours compared to transnasal fiberoptic laryngoscopy.
• To assess tumour growth during waiting times for completion of the diagnostic
phase by standardized judgment of first videolaryngoscopy approximately 2-3
weeks earlier and comparison with study videolaryngoscopy.
• To determine the recurrence rate in relation to the possibly more adequate
delineation of the lesions with the use of transnasal videolaryngoscopy and the
early detection of recurrence during follow up.
• To compare cost-effectiveness of transnasal videolaryngoscopy in outpatient
practice to direct laryngoscopy under general anaesthesia.
• To ascertain patient general and disease-specific quality of life and voice
handicap index.

Study design will be a prospective descriptive study.

Patients participating in this study get an extra opportunity to see video
images of the tumour without any additional risk caused by the two extra
transnasal laryngoscopies. Furthermore, the two quality of life questionnaires
are short and don*t contain detailed intimated personal questions. Potential
additional tiny (2-3 millimeters) biopsies, during rigid laryngoscopy in
general anesthesia based on videolaryngoscopic image with or without i-scan
filters of suspected tumour extension, are harmless and may be of great
interest in precise tumour delineation and staging, and therefore accurate
treatment. There are no extra visits necessary for study participation.
If videolaryngoscopy is proven to be accurate, the need for direct laryngoscopy
under general anaesthesia is obviated and thereby the need for pre-operative
consultation of anaesthesiologists, the risks of general anaesthesia in
patients with often significant comorbidity and possible delay in treatment.
More timely treatment is likely to result in a reduction of the duration of
uncertainty and anxiety for the patient. Lastly, it may decrease health care
costs and improve outcome.