Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma (HNSCC)
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Purpose
Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients.
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.
| Condition | Intervention |
|---|---|
|
Squamous Cell Carcinomas of the Head and Neck |
Procedure: Esophagoscopy and chromoendoscopy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma in Patients With Squamous Cell Carcinomas of the Head and Neck? |
- To detect early synchronous second primary esophageal carcinoma [ Time Frame: The primary measure was assessed immediately after the completion of the study by individual patients. ] [ Designated as safety issue: No ]
To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).
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.
| Enrollment: | 132 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Procedure: 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. |
Detailed Description:
ABSTRACT Objective: To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with newly diagnosed head and neck carcinoma
Inclusion Criteria:
- Newly diagnosed patients with head and neck carcinoma
- Age 18-65
Exclusion Criteria:
- Recurrent head and neck carcinomas
- Previously diagnosed oesophageal cancer
Contacts and Locations| Czech Republic | |
| University Hospital Ostrava | |
| Ostrava, Czech Republic, 70800 | |
| Principal Investigator: | Pavel Kominek, MD, PhD, MSc | University Hospital Ostrava |
More Information
Publications:
| Responsible Party: | University Hospital Ostrava |
| ClinicalTrials.gov Identifier: | NCT01783158 History of Changes |
| Other Study ID Numbers: | RVO-FNOs/2012 |
| Study First Received: | January 23, 2013 |
| Last Updated: | January 31, 2013 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
Keywords provided by University Hospital Ostrava:
|
head and neck carcinoma chromoendoscopy Lugol's solution esophageal carcinoma |
synchronous tumors deglutition deglutition disorders Newly diagnosed HNSCC |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 19, 2013