Early Detection of Oropharyngeal and Hypopharyngeal Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma by White Light Imaging and Optical Enhancement(OE)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- detect rate
研究概览
简要总结
the investigators randomly divide the eligible objects into two groups:1. objects in this group will first receive OE endoscopy observation and subsequent white light imaging(WLI) observation during oropharynx and hypopharynx; 2. objects in this group will first receive WLI observation and subsequent OE observation during oropharynx and hypopharynx. Then, the investigators will compare the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma of two groups to find if OE endoscopy can improve the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma in esophageal cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •order than 18 years old
- •Previous or current histopathological pathology confirmed the presence of esophageal squamous cell carcinoma
排除标准
- •Previously confirmed pharynx/oropharyngeal squamous cell carcinoma
- •Advanced pharynx/hypopharyngeal squamous cell carcinoma
- •Pregnant women and lactating women
- •pharyngeal or esophageal stenosis, esophageal varices, or active digestive tract hemorrhage influence the observation or fail to obtain pathological diagnosis
- •Previous chemotherapy or radiation therapy affected observation
- •Not completed gastroscopy or refused to take biopsy for various reasons
- •Mental illnesses such as anxiety and depression affect the endoscopic observation
- •Severe systemic disease, can not tolerate gastroscopy
- •Refusal to sign informed consent books
研究组 & 干预措施
first OE
干预措施: first OE (Device)
First WLI
干预措施: first WLI (Device)
结局指标
主要结局
detect rate
时间窗: 12 months
the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma
次要结局
未报告次要终点
研究者
Yanqing Li
vice president of Qilu Hospital
Shandong University