跳至主要内容
临床试验/NCT00927446
NCT00927446终止不适用

Endoscopy Screening for Esophageal Neoplasm With Narrow Band Imaging in Patients With Head and Neck Cancer: A Controlled Tandem Endoscopy Trial

Lotung Poh-Ai Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
40
试验地点
1
主要终点
Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia

研究概览

简要总结

Patients with head and neck cancer frequently develop synchronous or metachronous esophageal malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions. However, whether the application of NBI improves the detection results have not been critically evaluated.

This study aims to investigate the diagnostic value of the NBI system in the endoscopic screening for esophageal neoplastic lesions in patients with head and neck cancer.

详细描述

This is a prospective blinded controlled tandem endoscopy trial conducted in a regional medical center (Lotung Poh-Ai Hospital, Taiwan). Patients with tissue diagnosis of head and neck cancer are enrolled. Endoscopy screening for esophageal lesions is first performed by using the conventional white light system. Suspicious lesions are recorded. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy. After the endoscopic inspection completed, all suspicious lesions are biopsied. Before each procedure, which one of the two participating endoscopists applies the conventional or NBI system is randomized. The diagnostic rate of esophageal neoplasm by the conventional white light system and that of the NBI system are compared.

The endpoint is the neoplastic lesion detected on endoscopic biopsy. We considered invasive cancer, carcinoma in-situ, and high-grade dysplasia (which usually cannot be distinguished from carcinoma in situ) as the primary points. Any dysplastic lesions were considered as secondary points.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • patients with tissue diagnosis of head and neck cancer
  • histopathology of head and neck cancer is carcinoma (including squamous cell carcinoma, adenocarcinoma or undifferentiated)
  • aged more than 18 years old
  • agree to under go upper gastrointestinal endoscopy

排除标准

  • lack of written informed consent
  • the origin of head and neck cancer is metastatic
  • histopathology of head and neck cancer is not carcinoma (e.g., sarcoma, lymphoma, etc)
  • incomplete upper gastrointestinal endoscopy

结局指标

主要结局

Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia

时间窗: Within 3 days of endoscopy examination

次要结局

  • Pathological interpretation of biopsy specimen for any grade of dysplasia(within 3 days of endoscopy examination)

研究者

发起方
Lotung Poh-Ai Hospital
申办方类型
Other

研究点 (1)

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