Clinical trial NCT02035735: Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers
Official title: Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Squamous Cell Carcinoma of Oropharynx
Squamous Cell Carcinoma of Hypopharynx
Squamous Cell Carcinoma of Larynx
Keywords: NBI,
squamous cell carcinoma,
pharynx, larynx, surgical margins.
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of patients for whom superficial extension of the tumors has been increased by NBI.
timeFrame: 4 minutes
Secondary outcomes:
measure: Number of tumors upstaged.
timeFrame: 4 minutes
measure: Contribution of the NBI in the diagnosis of other synchronous locations.
timeFrame: 4 minutes
measure: Contribution of the NBI in the diagnosis of pre-neoplastic lesions.
timeFrame: 4 minutes
measure: Contribution of the NBI in the evaluation of surgical margins.
timeFrame: 4 minutes
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Sébastien VERGEZ, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chabrillac E, Espinasse G, Lepage B, Uro-Coste E, Dupret-Bories A, De Bonnecaze G, Vergez S. Contribution of narrow band imaging in delineation of laryngopharyngeal superficial cancer spread: a prospective study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1491-1497. doi: 10.1007/s00405-020-06499-2. Epub 2021 Jan 5.