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Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02035735
Enrollment
93
Registered
2014-01-14
Start date
2014-01-31
Completion date
2017-10-31
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx, Squamous Cell Carcinoma of Oropharynx

Keywords

NBI,, squamous cell carcinoma,, pharynx, larynx, surgical margins.

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.

Interventions

PROCEDUREWL 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).

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients for whom superficial extension of the tumors has been increased by NBI.4 minutes

Secondary

MeasureTime frame
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
Number of tumors upstaged.4 minutes
Contribution of the NBI in the diagnosis of other synchronous locations.4 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026