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Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract (TNFE-NBI)

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. Read our disclaimer for details. 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Recruitment Status : Withdrawn (Unable to obtain funding to continue recruitment; no accrual)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
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This study will compare TNFE-NBI and biopsy, with DRE and biopsy for the diagnostic evaluation and staging of patients with suspicious UADT lesions. All patients enrolled in the study will undergo TNFE-NBI with biopsy of suspicious lesions prior to planned regular clinical care (DRE). Biopsies will be evaluated by standard clinical methods for patient diagnoses and care. As the current standard of care, if all biopsies for a given patient are non-malignant, a 3 month office visit will be arranged to evaluate and determine the need for further intervention. At the end of study enrollment both sets of biopsies will be re-evaluated in a blinded fashion by the surgical pathologist. Study assessment of malignant vs. non-malignant (benign) pathology will be used to see whether both tests tended to agree on diagnoses.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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).

  5. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age eighteen years or older
  • Patients who are pending operative direct laryngoscopy as standard clinical care
  • Presence of upper aerodigestive tract (UADT) (oropharyngeal, hypopharyngeal and/or glottic mucosal) lesion(s) suspicious for diagnoses including but not limited to: squamous cell carcinoma, carcinoma in situ, squamous dysplasia, papilloma, OR presence of diagnosed metastatic squamous cell carcinoma in the neck with an unidentified primary lesion
  • Ability to give written informed consent and willingness to comply with the requirements of the protocol

Exclusion Criteria:

  • Patients who are not medically able to undergo TNFE
  • Allergy to topical anesthesia
  • Active lymphoma
  • Lesion inaccessibility to TNFE: oral cavity (anterior 2/3 tongue, buccal mucosa)
  • Coagulopathy: INR ≥ 1.5
  • Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator such as anxiety or narrow nasal passage way.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01175499

Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Mark S. Courey, MD UCSF Helen Diller Family Comprehensive Cancer Center, Otolaryngology, Head & Neck Surgery

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Responsible Party: University of California, San Francisco Identifier: NCT01175499    
Other Study ID Numbers: 10-00166
10201 ( Other Identifier: UCSF Helen Diller Family Comprehensive Cancer Center )
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Keywords provided by University of California, San Francisco:
Laryngoscopic Surgery
upper aerodigestive tract lesions
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Oropharyngeal Neoplasms
Carcinoma, Squamous Cell
Hypopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases