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临床试验/NCT01896310
NCT01896310已完成不适用

New Classification of Gastric Pit Patterns and Vessel Architecture Using Probe-based Confocal Laser Endomicroscopy

Shandong University1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2013年6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
272
试验地点
1
主要终点
The diagnostic accuracy of the new classification system

研究概览

简要总结

The aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

详细描述

Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device which allows the application of laser microscopy with any conventional endoscope and mosaic imaging. Previous studies have demonstrated its application in various GI diseases, including Barrett's esophagus, colonic adenoma, ulcerative colitis, and etc. However, limited data are provided on exploring the application of pCLE in the stomach. Therefore, the aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

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 scheduled for pCLE examination
  • aged between 18 and 80 years old

排除标准

  • Esophageal, gastric or duodenal cancer or other malignancy
  • History of upper GI tract surgery
  • Coagulopathy or bleeding disorders
  • Allergy to fluorescein sodium
  • Pregnant or breast-feeding (for females)
  • Impaired renal function

结局指标

主要结局

The diagnostic accuracy of the new classification system

时间窗: 3 month

Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of the new classification of gastric pit patterns and vessel architecture using probe-based confocal laser endomicroscopy

次要结局

未报告次要终点

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanqing Li

Vice president of Qilu Hospital

Shandong University

研究点 (1)

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