Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Image Quality
研究概览
简要总结
The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.
详细描述
Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, there is no study to investigate the sequence of Lugol's staining during endoscopic procedure.
The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •High risk patients of early esophageal squamous neoplasias.
排除标准
- •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
Image Quality
时间窗: intraoperative
Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.
次要结局
- Tolerance(intraoperative)
- Effectiveness(1 month)
- Dose(intraoperative)
- Adverse events(24 hours)
研究者
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University