Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma

Completed

• Conditions: Squamous Cell Carcinomas of the Head and Neck
• Interventions: Procedure: Esophagoscopy and chromoendoscopy

• Registration Number: NCT01783158
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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.

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-01
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Study First Posted: 2013-02-04
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Newly diagnosed patients with head and neck carcinoma
• Age 18-65

Exclusion Criteria

• Recurrent head and neck carcinomas
• Previously diagnosed oesophageal cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic group	Esophagoscopy and chromoendoscopy	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.

Primary Outcome Measures

Name	Time	Method
To detect early synchronous second primary esophageal carcinoma	The primary measure was assessed immediately after the completion of the study by individual patients.	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.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Czech Republic