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临床试验/NCT02002559
NCT02002559已完成不适用

Endoscopic Surveillance Comparing Narrow Band Imaging (NBI) Against Lugol Chromoendoscopy for Detection of Synchronous Superficial Squamous Esophageal Neoplasia Among High Risk Patients

Chinese University of Hong Kong0 个研究点目标入组 180 人开始时间: 2006年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
主要终点
Diagnostic accuracy of superficial esophageal neoplasia

研究概览

简要总结

This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for diagnosis of early esophageal cancers among high risk patients.

详细描述

The investigators recruited consecutive patients with head and neck cancers, history of squamous esophageal cancers treated by chemoradiotherapy or endoscopic resection. Endoscopic surveillance first started with NBI for detection and characterization of early esophageal cancers through observation of abnormal intrapapillary capillary loops (IPCL). Superficial esophageal neoplasia were diagnosed by IPCL Type IV, V1,V2 and Vn. Lugol chromoendoscopy would be performed subsequently and suspicious neoplasia were classified as understain or unstain lesions. The diagnostic accuracy, sensitivity and specificity of NBI were compared to Lugol chromoendoscopy with histology serving as a gold standard.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Head and Neck Cancer
  • Patients with esophageal cancer treated by chemoradiotherapy and in remission for 2 years
  • Patients with esophageal cancer treated by endoscopic resection
  • Age 18 to 80

排除标准

  • Allergy to Lugol iodine
  • Previous esophagectomy

结局指标

主要结局

Diagnostic accuracy of superficial esophageal neoplasia

时间窗: 1 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philip Wai Yan Chiu

Professor

Chinese University of Hong Kong

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