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Clinical Trials/NCT02035735
NCT02035735
Completed
Not Applicable

Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx

University Hospital, Toulouse1 site in 1 country93 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Squamous Cell Carcinoma of Oropharynx
Sponsor
University Hospital, Toulouse
Enrollment
93
Locations
1
Primary Endpoint
Number of patients for whom superficial extension of the tumors has been increased by NBI.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
October 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who can benefit a laryngoscopic exam under general anesthesia

Exclusion Criteria

  • General anesthesia contra-indications
  • Local anesthesia allergy
  • Breast-feeding period or pregnancy

Outcomes

Primary Outcomes

Number of patients for whom superficial extension of the tumors has been increased by NBI.

Time Frame: 4 minutes

Secondary Outcomes

  • Number of tumors upstaged.(4 minutes)
  • Contribution of the NBI in the diagnosis of pre-neoplastic lesions.(4 minutes)
  • Contribution of the NBI in the evaluation of surgical margins.(4 minutes)
  • Contribution of the NBI in the diagnosis of other synchronous locations.(4 minutes)

Study Sites (1)

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