Value of Narrow Band Imaging (NBI) Endoscopy in the Early Diagnosis of Laryngeal Cancer and Precancerous Lesions
2 other identifiers
interventional
150
1 country
1
Brief Summary
The aim of the project is to compare NBI endoscopy and standard endoscopic method using white light and evaluate accuracy both methods in early detection and diagnosis hypopharyngeal and laryngeal precancerous and cancerous lesions. A higher contrast between the mucosal epithelium and blood vessels is achieved in NBI endoscopy using filtered light comparing to white light observations. This allows detection of small mucosal changes, few millimetres in diameter, which are not observable using white light. The second aim in patients with squamous cell carcinoma of the upper aerodigestive tract is to compare extension of mucosal lesions by evaluation of NBI endoscopy and white light endoscopy, which is crucial for perform targeted biopsy and for determination of resection margins in cancer surgery. The investigators expect that dysplastic changes of mucosa or early laryngeal cancerous lesions are detected in white light endoscopy rarely. In case our hypothesis is confirmed, frequency of precancerous and early cancerous lesions of hypopharynx and larynx is more common in patients with non-specific symptoms of laryngeal and pharyngeal diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 31, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedSeptember 8, 2016
September 1, 2016
4.1 years
July 31, 2014
September 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The number of patients with larger extent of the laryngeal lesison on NBI examination when compared to standard white light endoscopy
The extension of mucosal lesions will be assessed by evaluation of NBI endoscopy and white light endoscopy, together with evaluation of spreading of cancer in mucosa. The total number of patients with larger extent of the laryngeal lesion on NBI examination will be determined, in comparison with the results obtained with standard white light endoscopy.
3 years
The number of patients with histologically proven laryngeal cancer
Findings on NBI endoscopy will be compared to findings obtained with white light endoscopy; the usefulness of both methods will be assessed. The number of patients with histologically proven laryngeal cancer will be determined.
3 years
Study Arms (1)
NBI endoscopy
EXPERIMENTAL150 patients with suspected lesion in larynx and hypopharynx on standard ENT white light endoscopy examination will undergo NBI endoscopy in order to compare the outcomes of these two examination methods
Interventions
Eligibility Criteria
You may qualify if:
- patients in age 30-80 years
- patients with chronic inflammation of hypopharynx and larynx longer than 3 months (with pain in throat, globbus pharyngeal,…) and/or
- patients with hoarseness longer than 3 weeks and/or
- patients with macroscopic laryngeal lesions (leukoplakia, erythroplakia, Reinke oedema, excluded polyps, cystic lesions and nodules)
- patients with histological confirmation of dysplasia and/or
- patients with carcinoma in situ/invasive carcinoma of hypopharynx or larynx and/or
- patients with recurrent respiratory papillomatosis of all ages
You may not qualify if:
- inability to undergo endoscopic examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852, Czechia
Related Publications (4)
Watanabe A, Taniguchi M, Tsujie H, Hosokawa M, Fujita M, Sasaki S. The value of narrow band imaging for early detection of laryngeal cancer. Eur Arch Otorhinolaryngol. 2009 Jul;266(7):1017-23. doi: 10.1007/s00405-008-0835-1. Epub 2008 Nov 4.
PMID: 18982341BACKGROUNDNi XG, He S, Xu ZG, Gao L, Lu N, Yuan Z, Lai SQ, Zhang YM, Yi JL, Wang XL, Zhang L, Li XY, Wang GQ. Endoscopic diagnosis of laryngeal cancer and precancerous lesions by narrow band imaging. J Laryngol Otol. 2011 Mar;125(3):288-96. doi: 10.1017/S0022215110002033. Epub 2010 Nov 8.
PMID: 21054921BACKGROUNDPiazza C, Dessouky O, Peretti G, Cocco D, De Benedetto L, Nicolai P. Narrow-band imaging: a new tool for evaluation of head and neck squamous cell carcinomas. Review of the literature. Acta Otorhinolaryngol Ital. 2008 Apr;28(2):49-54.
PMID: 18669067BACKGROUNDPiazza C, Cocco D, De Benedetto L, Del Bon F, Nicolai P, Peretti G. Narrow band imaging and high definition television in the assessment of laryngeal cancer: a prospective study on 279 patients. Eur Arch Otorhinolaryngol. 2010 Mar;267(3):409-14. doi: 10.1007/s00405-009-1121-6. Epub 2009 Oct 14.
PMID: 19826829BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pavel Kominek, MD,PhD,MBA
University Hospital Ostrava
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2014
First Posted
August 15, 2014
Study Start
February 1, 2012
Primary Completion
March 1, 2016
Study Completion
May 1, 2016
Last Updated
September 8, 2016
Record last verified: 2016-09