Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers

Squamous Cell Carcinoma of Oropharynx Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035735
• Other study ID #: 13 203 02
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: October 2017

Study information

• Verified date: December 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Laryngeal Diseases
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma of Hypopharynx
• Squamous Cell Carcinoma of Larynx
• Squamous Cell Carcinoma of Oropharynx

Intervention

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).

Locations

Country	Name	City	State
France	University of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients for whom superficial extension of the tumors has been increased by NBI.		4 minutes
Secondary	Number of tumors upstaged.		4 minutes
Secondary	Contribution of the NBI in the diagnosis of other synchronous locations.		4 minutes
Secondary	Contribution of the NBI in the diagnosis of pre-neoplastic lesions.		4 minutes
Secondary	Contribution of the NBI in the evaluation of surgical margins.		4 minutes