Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers
Primary Purpose
Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
WL and NBI
Sponsored by
About this trial
This is an interventional diagnostic trial for Squamous Cell Carcinoma of Oropharynx focused on measuring NBI,, squamous cell carcinoma,, pharynx, larynx, surgical margins.
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
Sites / Locations
- University of Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Videoendoscopy with WL and NBI
Arm Description
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).
Outcomes
Primary Outcome Measures
Number of patients for whom superficial extension of the tumors has been increased by NBI.
Secondary Outcome Measures
Number of tumors upstaged.
Contribution of the NBI in the diagnosis of other synchronous locations.
Contribution of the NBI in the diagnosis of pre-neoplastic lesions.
Contribution of the NBI in the evaluation of surgical margins.
Full Information
NCT ID
NCT02035735
First Posted
January 10, 2014
Last Updated
December 9, 2018
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02035735
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx
Keywords
NBI,, squamous cell carcinoma,, pharynx, larynx, surgical margins.
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Videoendoscopy with WL and NBI
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
WL and NBI
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of patients for whom superficial extension of the tumors has been increased by NBI.
Time Frame
4 minutes
Secondary Outcome Measure Information:
Title
Number of tumors upstaged.
Time Frame
4 minutes
Title
Contribution of the NBI in the diagnosis of other synchronous locations.
Time Frame
4 minutes
Title
Contribution of the NBI in the diagnosis of pre-neoplastic lesions.
Time Frame
4 minutes
Title
Contribution of the NBI in the evaluation of surgical margins.
Time Frame
4 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien VERGEZ, MD, PhD
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33398548
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.
Results Reference
derived
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Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers
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