An interventional study of WL and NBI in Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx and Squamous Cell Carcinoma of Larynx, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-11.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Diagnostic
The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.
Several studies have already showed the interest of the use of NBI for the early diagnosis of malignancies of the upper aerodigestive tract. For all tumors, the most accurate evaluation of its limits is very important to perform the best strategy of treatment. If surgery seems to be the best option, surgical margins must be widely healthy. Despite the systematic transnasal flexible endoscopy with white lamp followed by laryngoscopy under general anesthesia (LGA) and tomodensitometric evaluation, surgical margins can be unhealthy (in situ carcinoma or dysplasia). We propose to evaluate if the use of the NBI could be useful to determine the superficial spread of squamous cell carcinomas in these locations.
To April 2013 to Mars 2015, all patients with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx and whom a LGA are expected, are included. The day before the LGA, two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light and the second one with NBI. All results are noted on a schema. Superficial extension or synchronous lesions showed by NBI are analysed and compared with with lamp technic.
After surgery, surgical margins were evaluated and healthy margins were measured.
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This study's enrollment of 93 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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The day before the laryngoscopy under general anesthesia (LGA), two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light (WL) and the second one with NBI (NBI).
Procedure: WL and NBI
For each patient with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx for whom a laryngoscopy under general anesthesia (LGA) is expected benefit the day before a transnasal endoscopy with white lamp (WL) and NBI by two different operators. Suspected mucosal abnormalities showed by one or the two technics are reported in a table wich describes the different areas of the pharynx and the larynx. During the LGA, several biopsies are performed and identified (WL and/or NBI).
Number of patients for whom superficial extension of the tumors has been increased by NBI.
Time frame: 4 minutes
Number of tumors upstaged.
Time frame: 4 minutes
Contribution of the NBI in the diagnosis of other synchronous locations.
Time frame: 4 minutes
Contribution of the NBI in the diagnosis of pre-neoplastic lesions.
Time frame: 4 minutes
Contribution of the NBI in the evaluation of surgical margins.
Time frame: 4 minutes
Plan to share: No
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse