Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers

Not Applicable

Completed

• Conditions: Squamous Cell Carcinoma of Larynx; Squamous Cell Carcinoma of Oropharynx; Squamous Cell Carcinoma of Hypopharynx
• Interventions: Procedure: WL and NBI

• Registration Number: NCT02035735
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-09
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Videoendoscopy with WL and NBI	WL and NBI	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).

Primary Outcome Measures

Name	Time	Method
Number of patients for whom superficial extension of the tumors has been increased by NBI.	4 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Toulouse; 🇫🇷 Toulouse, France