NCT02851264Unknown不适用
Diagnostic Value of Virtual Chromoendoscopy With Optical Enhancement Technology in Early Esophageal Squamous Neoplasia: A Prospective Comparative Study
Shandong University1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2016年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- The detection rate of early esophageal squamous neoplasia by optical enhancement technology.
研究概览
简要总结
The aims of the present study：
- To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia.
- To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .
详细描述
Detection and differentiation of esophageal squamous neoplasia (ESN) are of value in improving patient outcomes.Optical enhancement technology can serves in the diagnosis of GI neoplasia. However, its performance in ESN has not yet been reported.The aims of the present study is:
- To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia.
- To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .
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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with high-risk factors for esophageal squamous cell carcinoma who meet any of follows：
- •Long term living in the high incidence area of esophageal squamous cell carcinoma ；
- •First degree relatives have a history of esophageal squamous cell carcinoma ；
- •Previous history of esophageal lesions （ esophageal squamous neoplasia ）；
- •The patients having a history of cancer；
- •A long history of smoking ；
- •A long history of drinking ；
- •Having bad eating habits such as eating fast, hot diet, high salt diet, eating pickles.
- •Patients aged between 40 to 74 years old.
排除标准
- •Having advanced esophageal carcinoma;
- •After esophageal surgery or endoscopic treatment ;
- •Known esophageal radiotherapy or chemotherapy ;
- •Esophageal stenosis;
- •Acute bleeding;
- •A known allergy to iodine;
- •Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds);
- •Having food retention;
- •Severe hepatic ,renal, cardiovascular or metabolic dysfunction ;
- •Being pregnant or lactating;
结局指标
主要结局
The detection rate of early esophageal squamous neoplasia by optical enhancement technology.
时间窗: 12 months
The detection rate of early esophageal squamous neoplasia by using optical enhancement and Lugol chromoendoscopy.
次要结局
- The diagnostic accuracy of optical enhancement technology on early esophageal squamous neoplasia.(12 months)
- The observation time of optical enhancement and Lugol chromoendoscopy.(12 months)
- The different rate of adverse events between optical enhancement and Lugol chromoendoscopy.(12 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University
研究点 (1)
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