Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02035735|
Recruitment Status : Recruiting
First Posted : January 14, 2014
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of Oropharynx Squamous Cell Carcinoma of Hypopharynx Squamous Cell Carcinoma of Larynx||Procedure: WL and NBI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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).
- Number of patients for whom superficial extension of the tumors has been increased by NBI. [ Time Frame: 4 minutes ]
- Number of tumors upstaged. [ Time Frame: 4 minutes ]
- Contribution of the NBI in the diagnosis of other synchronous locations. [ Time Frame: 4 minutes ]
- Contribution of the NBI in the diagnosis of pre-neoplastic lesions. [ Time Frame: 4 minutes ]
- Contribution of the NBI in the evaluation of surgical margins. [ Time Frame: 4 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035735
|Contact: Sébastien VERGEZ, MD, PhD||05 67 77 18 07 ext firstname.lastname@example.org|
|Contact: Gaël ESPINASSE, Resident||06 23 79 39 email@example.com|
|University of Toulouse||Recruiting|
|Toulouse, France, 31059|
|Contact: Sébastien VERGEZ, MD, PhD 05 67 77 18 07 ext 33 firstname.lastname@example.org|
|Contact: Amandine PAUZE 05 61 77 83 47 ext 33 email@example.com|
|Sub-Investigator: Virginie WOISARD|
|Sub-Investigator: Benjamin VAIREL|
|Principal Investigator:||Sébastien VERGEZ, MD, PhD||University Hospital of Toulouse|