Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract (TNFE-NBI)
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|ClinicalTrials.gov Identifier: NCT01175499|
Recruitment Status : Withdrawn (Unable to obtain funding to continue recruitment; no accrual)
First Posted : August 4, 2010
Last Update Posted : August 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Upper Aerodigestive Tract Lesions Neoplasms, Oropharyngeal Oropharyngeal Cancer Neoplasms, Hypopharyngeal Hypopharyngeal Cancer Head and Neck Neoplasms UADT Neoplasms Carcinoma, Squamous Cell Papilloma||Device: Direct Rigid Endoscopy Device: Transnasal Flexible Endoscopy with Narrowband Imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Accuracy of Endoscopic Diagnosis of Carcinoma of the UpperAerodigestive Tract: A Tandem Trial of Direct Rigid Endoscopy and Transnasal Flexible Endoscopy With Narrowband Imaging|
|Study Start Date :||July 2010|
- Device: Direct Rigid Endoscopy
Laryngoscopy is performed under general anesthesia with a rigid laryngoscope. Mucosal surfaces of the oropharynx, hypopharynx, and glottis (base of tongue, vallecula, epiglottis, aryepiglottic folds, arytenoids, piriform sinuses, true and false vocal cords, and esophageal inlet) are systematically visualized. Areas of irregularity are biopsied with 2mm and/or 4mm cupped forceps. Esophagoscopy and bronchoscopy will be performed per the standard of care.Other Name: Rigid laryngoscope
- Device: Transnasal Flexible Endoscopy with Narrowband Imaging
Transnasal flexible endoscopy with and without narrowband imaging- additional diagnostic test. This examination is performed after topical intranasal anesthesia with 2% Pontocaine spray. A fiberoptic laryngoscope is passed into the nasal cavity to the pharynx where mucosal surfaces of the UADT can be visualized. The optics of a standard fiberoptic scope are generally considered to be inferior to direct visualization. The addition of narrowband imaging does not change the procedure, but enhances visualization of the mucosal vasculature. Biopsies are performed through a second channel in the endoscope with 1.8mm cupped forceps and will require an additional dose of topical anesthesia.Other Name: EVIS EXERA 160A System
- Agreement between TNFE-NBI and DRE [ Time Frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed ]
At the conclusion of study enrollment, all biopsy specimens will be coded, de-identified, and re-evaluated by the study pathologist in a blinded fashion. The code will be broken for the purposes of study analyses.
If all biopsies taken by both procedures on each patient are diagnosed as non-malignant upon blinded evaluation by the study pathologist or if both procedures have at least one biopsy diagnosed as malignant, this will be considered concordance.
- Agreement of TNFE-NBI and DRE on tumor stage and location [ Time Frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed ]Describe differences, if any, in characterization of AJCC cTNM stage and tumor location as determined by TNFE-NBI as compared to standard-of-care DRE
- Agreement between TNFE-NBI and DRE on biopsy location selection [ Time Frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed ]describe differences, if any, in biopsy location during TNFE-NBI as compared to standard-of-care DRE
- False negative diagnoses by TNFE-NBI or DRE [ Time Frame: Approximately 4 months after enrollment, after completion of both procedures and 3-month follow-up for non-malignant diagnoses ]To describe the frequency of detecting malignancy at a 3-month follow-up for patients initially diagnosed as negative for malignancy by both TNFE NBI and DRE evaluations
- Frequency and Timing of Adverse Events [ Time Frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed and patient follow-up at 30 days ]The frequency by grade for all adverse events will be tabulated by type and procedure as well as timing (during or immediately following study procedure vs. follow-up).
- Describe patient tolerance for TNFE-NBI [ Time Frame: At the time of TNFE-NBI procedure, study day 1 ]Patients who have fulfilled the inclusion criteria and are unable to tolerate the unsedated examination will be classified as having non-concordance between TNFE-NBI and DRE (because a diagnosis could not be made based upon pathology) and the reason for intolerance to the procedure recorded.
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): NCT01175499
|Principal Investigator:||Mark S. Courey, MD||UCSF Helen Diller Family Comprehensive Cancer Center, Otolaryngology, Head & Neck Surgery|