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临床试验/NCT02182804
NCT02182804已完成不适用

Diagnostic Values of Probe-based Confocal Laser Endomicroscopy (pCLE) and Magnifying Narrow Band Imaging (M-NBI) for Early Neoplasms Detection in Esophageal Lugol'S-voiding Lesions.

King Chulalongkorn Memorial Hospital0 个研究点目标入组 44 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
主要终点
Accuracy

研究概览

简要总结

This descriptive cross sectional study aims to directly compare the diagnostic capability of the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging (M-NBI) in the Lugol's voiding lesions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Age over 20 years
  • •Having histological-confirmed diagnosis of head and neck cancer
  • •Having no esophageal symptoms

排除标准

  • •Having index cancer of nasopharynx
  • •History of esophageal surgery
  • •Having esophageal stricture or obstruction
  • •Having esophageal varices
  • •Known case of esophageal cancer
  • •Uncorrectable coagulopathy and thrombocytopenia
  • •Pregnancy
  • •Thyrotoxicosis
  • •Creatinine clearance less than 30 ml/min
  • •Allergy to iodine or fluorescein.

研究组 & 干预措施

Study

Experimental

probe-based confocal laser endomicroscopy narrow band imaging with magnification

干预措施: Olympus (Device)

Study

Experimental

probe-based confocal laser endomicroscopy narrow band imaging with magnification

干预措施: Cellvizio (Device)

结局指标

主要结局

Accuracy

时间窗: an expected average of 2 weeks

Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.

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

Rapat Pittayanon

Gastroenterologist

King Chulalongkorn Memorial Hospital

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