Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma (HNSCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01783158
First received: January 23, 2013
Last updated: January 31, 2013
Last verified: January 2013
  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?

Resource links provided by NLM:


Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • 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
Study Population

Patients with newly diagnosed head and neck carcinoma

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783158

Locations
Czech Republic
University Hospital Ostrava
Ostrava, Czech Republic, 70800
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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 Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on October 23, 2014