Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract

NCT01175499 | Withdrawn

• 2 other identifiers: 10-0016610201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Upper Aerodigestive Tract Lesions; Neoplasms, Oropharyngeal; Oropharyngeal Cancer; Neoplasms, Hypopharyngeal; Hypopharyngeal Cancer; Head and Neck Neoplasms; UADT Neoplasms; Carcinoma, Squamous Cell; Papilloma

Keywords

laryngoscopy; Laryngoscopic Surgery; laryngoscopes; upper aerodigestive tract lesions; endoscopy; biopsy

Outcome Measures

Primary Outcomes (1)

• Agreement between TNFE-NBI and DRE

  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.

  Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed

Secondary Outcomes (5)

• Agreement of TNFE-NBI and DRE on tumor stage and location

  Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed

• Agreement between TNFE-NBI and DRE on biopsy location selection

  Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed

• False negative diagnoses by TNFE-NBI or DRE

  Approximately 4 months after enrollment, after completion of both procedures and 3-month follow-up for non-malignant diagnoses

• Frequency and Timing of Adverse Events

  Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed and patient follow-up at 30 days

• Describe patient tolerance for TNFE-NBI

  At the time of TNFE-NBI procedure, study day 1

Interventions

Direct Rigid Endoscopy DEVICE

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.

Also known as: Rigid laryngoscope

Transnasal Flexible Endoscopy with Narrowband Imaging DEVICE

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.

Also known as: EVIS EXERA 160A System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Papilloma

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Mark S. Courey, MD

  UCSF Helen Diller Family Comprehensive Cancer Center, Otolaryngology, Head & Neck Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: August 4, 2010
• Study Start: July 1, 2010
• Last Updated: August 19, 2014

Record last verified: 2014-08