Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02035735
First received: January 10, 2014
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Squamous Cell Carcinoma of Oropharynx
Squamous Cell Carcinoma of Hypopharynx
Squamous Cell Carcinoma of Larynx
Procedure: WL and NBI

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Number of patients for whom superficial extension of the tumors has been increased by NBI. [ Time Frame: 4 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of tumors upstaged. [ Time Frame: 4 minutes ] [ Designated as safety issue: Yes ]
  • Contribution of the NBI in the diagnosis of other synchronous locations. [ Time Frame: 4 minutes ] [ Designated as safety issue: Yes ]
  • Contribution of the NBI in the diagnosis of pre-neoplastic lesions. [ Time Frame: 4 minutes ] [ Designated as safety issue: Yes ]
  • Contribution of the NBI in the evaluation of surgical margins. [ Time Frame: 4 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 87
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Videoendoscopy with 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).
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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients'age : >18 years
  • Patients who can benefit a laryngoscopic exam under general anesthesia

Exclusion Criteria:

  • Minors patients
  • General anesthesia contra-indications
  • Local anesthesia allergy
  • Breast-feeding period or pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035735

Contacts
Contact: Sébastien VERGEZ, MD, PhD 05 67 77 18 07 ext 33 vergez.s@chu-toulouse.fr
Contact: Gaël ESPINASSE, Resident 06 23 79 39 69. gaelespinasse@hotmail.com

Locations
France
University of Toulouse Recruiting
Toulouse, France, 31059
Contact: Sébastien VERGEZ, MD, PhD    05 67 77 18 07 ext 33    vergez.s@chu-toulouse.fr   
Contact: Sandrine GASCON    05 61 77 83 47 ext 33    gascon.s@chu-toulouse.fr   
Sub-Investigator: Virginie WOISARD         
Sub-Investigator: Benjamin VAIREL         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Sébastien VERGEZ, MD, PhD University Hospital of Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02035735     History of Changes
Other Study ID Numbers: 13 203 02
Study First Received: January 10, 2014
Last Updated: August 27, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
NBI,
squamous cell carcinoma,
pharynx, larynx, surgical margins.

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 20, 2014