The Value of Mesenchymal Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Accuracy of black spots in diagnosis of gastric intestinal metaplasia
研究概览
简要总结
The study aims to:
- Explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy (CLE).
- Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.
详细描述
Gastric intestinal metaplasia (GIM) is confirmed to be a risk factor that may lead to the development of intestinal type gastric cancer. Previous study has shown that confocal laser endomicroscopy promising in the diagnosis of GIM. The investigators have found an elevated incidence of mesenchymal black spots in patients with GIM during previous CLE imaging. This study aims to explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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 will include male or female aged between 18 and 80 years with indications for upper-endoscopy , but without any disease of heart, liver or kidney.
排除标准
- •Patients who are allergic to fluorescein sodium
- •Patients who are unwilling to sign or give the informed consent form
- •Patients with impaired cardiac, liver or renal function
- •Patients with coagulopathy
- •Patients with pregnancy or breastfeeding
结局指标
主要结局
Accuracy of black spots in diagnosis of gastric intestinal metaplasia
时间窗: up to six months
次要结局
未报告次要终点
研究者
Yanqing Li
Vice President, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University
Shandong University