Different Lugol's Solution Concentration for Image Quality of Early Esophageal Squamous Neoplasia in Chromoendoscopy With Iodine Staining
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Image Quality of Esophageal Lesions
研究概览
简要总结
The purpose of this study is to assess whether lower Lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia.
详细描述
Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, this modality may cause severe chest pain and discomfort owing to mucosal irritation.
This study was to test whether a lower concentration of Lugol's solution can provide satisfied image quality of early esophageal squamous neoplasia and has lower mucosal irritation.
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
- Double (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
- •Patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection.
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.
研究组 & 干预措施
group 1
This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy.
干预措施: 1.2% Lugol's solution (Drug)
group 2
This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy.
干预措施: 1.0% Lugol's solution (Drug)
group 3
This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy.
干预措施: 0.8% Lugol's solution (Drug)
group 4
This group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy.
干预措施: 0.6% Lugol's solution (Drug)
group 5
This group patients were given dosages of 0.4% Lugol's solution for chromoendoscopy.
干预措施: 0.4% Lugol's solution (Drug)
结局指标
主要结局
Image Quality of Esophageal Lesions
时间窗: seven months
Evaluated by Image J software (National Institutes of Health)
次要结局
- Questionnaire of endoscopists' subjective assessments(intraoperative)
- Complete resection/R0 resection rate(1 month)
- The amount of Lugol's solution(intraoperative)
- Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.(intraoperative)
- Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)(1 month)
研究者
Xiuli Zuo
director of Qilu Hospital
Shandong University