跳至主要内容
临床试验/NCT01783158
NCT01783158已完成不适用

Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma in Patients With Squamous Cell Carcinomas of the Head and Neck?

University Hospital Ostrava1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
1
主要终点
To detect early synchronous second primary esophageal carcinoma

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Recurrent head and neck carcinomas
  • Previously diagnosed oesophageal cancer

结局指标

主要结局

To detect early synchronous second primary esophageal carcinoma

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (1)

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