Detection of Early Esophageal Squamous Neoplasia by Using Virtual Chromoendoscopy and Probe-based Confocal Laser Endomicroscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The diagnostic accuracy of pCLE on early esophageal squamous neoplasia
研究概览
简要总结
The aim of the present study：
- To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.
- To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy
详细描述
Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device and has shown its value for diagnosing Barrett's esophagus, colonal polyps and etc. However, none research has focus on early esophageal squamous neoplasia until now. Previous diagnosis of early esophageal neoplasia is based on the lugol staining which is time wasting and have many adverse events.Other researches have suggested virtual chromoendoscopys are beneficial for screening esophageal tumors. Therefore, the aim of the present study is 1.To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia according to the surface maturation scoring(SMS) diagnostic criteria and 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy(I-SCAN).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 50 and 80 years old
- •Patients undergo screening endoscopy or histologically verified esophageal squamous intraepithelial neoplasia before.
排除标准
- •Advanced esophageal, gastric or duodenal cancer
- •History of upper GI tract surgery
- •Coagulopathy or acute GI bleeding
- •Pregnant or breast-feeding (for females)
- •Impaired renal function
- •Allergy to fluorescein sodium
- •Inability to provide informed consent.
结局指标
主要结局
The diagnostic accuracy of pCLE on early esophageal squamous neoplasia
时间窗: 6 month
Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of early esophageal squamous neoplasia by using probe-based confocal laser endomicroscopy
次要结局
未报告次要终点
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University