Carcinoma in Situ Clinical Trial
Official title:
Value of Narrow Band Imaging (NBI) Endoscopy in the Early Diagnosis of Laryngeal Cancer and Precancerous Lesions
Verified date | September 2016 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | Czech Republic: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - inability to undergo endoscopic examination |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Czech Republic | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czech Republic,
Ni 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. — View Citation
Piazza 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. — View Citation
Piazza 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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
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