Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma
NCT ID: NCT01783158
Last Updated: 2013-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
132 participants
OBSERVATIONAL
2004-01-31
2012-12-31
Brief Summary
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Although only two patients with synchronous primary carcinomas were found among the patients with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced endoscopic methods should be recommended after detection of HNSCC to exclude secondary esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy and inexpensive option and can be done in most of gastroenterology offices.
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Detailed Description
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Methods: All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Diagnostic group
A total of 132 patients with HNSCC were enrolled in this study. The patients underwent esophagoscopy and chromoendoscopy. The most frequent primary tumors were oropharyngeal (49/132), tumors of the oral cavity (36/132) and larynx (35/132). The majority of subjects (107/132 patients, 81.1%) had advanced HNSCC carcinomas (stages III and IV). Multiple LVLs were discovered in 24 subjects (18.2%), and no LVLs in 108 (81.8%) subjects. Fifty-five LVL biopsy specimens were obtained and assessed. Squamous cell carcinomas were detected in two patients, peptic esophagitis in 11 patients, gastric heterotopic mucosa in two patients, hyperplasia in two patients, and low- and high-grade dysplasia in three patients.
Esophagoscopy and chromoendoscopy
Esophagoscopy - examination of the interior of the esophagus by means of an esophagoscope.
Chromoendoscopy - a method, which involves the topical application of stains or pigments to improve tissue localization, characterization, or diagnosis during endoscopy.
Interventions
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Esophagoscopy and chromoendoscopy
Esophagoscopy - examination of the interior of the esophagus by means of an esophagoscope.
Chromoendoscopy - a method, which involves the topical application of stains or pigments to improve tissue localization, characterization, or diagnosis during endoscopy.
Eligibility Criteria
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Inclusion Criteria
* Age 18-65
Exclusion Criteria
* Previously diagnosed oesophageal cancer
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Pavel Kominek, MD, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, , Czechia
Countries
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References
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Muto M, Hironaka S, Nakane M, Boku N, Ohtsu A, Yoshida S. Association of multiple Lugol-voiding lesions with synchronous and metachronous esophageal squamous cell carcinoma in patients with head and neck cancer. Gastrointest Endosc. 2002 Oct;56(4):517-21. doi: 10.1067/mge.2002.128104.
SLAUGHTER DP, SOUTHWICK HW, SMEJKAL W. Field cancerization in oral stratified squamous epithelium; clinical implications of multicentric origin. Cancer. 1953 Sep;6(5):963-8. doi: 10.1002/1097-0142(195309)6:53.0.co;2-q. No abstract available.
Fukuhara T, Hiyama T, Tanaka S, Oka S, Yoshihara M, Arihiro K, Chayama K. Characteristics of esophageal squamous cell carcinomas and lugol-voiding lesions in patients with head and neck squamous cell carcinoma. J Clin Gastroenterol. 2010 Feb;44(2):e27-33. doi: 10.1097/MCG.0b013e3181b31325.
Other Identifiers
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RVO-FNOs/2012
Identifier Type: -
Identifier Source: org_study_id
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