Clinical Trial: Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University Hospital, Toulouse

Current Primary Outcome: Number of patients for whom superficial extension of the tumors has been increased by NBI. [ Time Frame: 4 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: January 10, 2014
Date Started: January 2014
Date Completion: December 2017
Last Updated: February 21, 2017
Last Verified: February 2017