Cresyl Violet as a New Contrast Agent in Confocal Laser Endomicroscopy for in Vivo Diagnosis of Gastric Intestinal Metaplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- feasibility of CV for identifying GIM
研究概览
简要总结
Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above
- •patients with H. pylori infection, or known GIM or atrophic gastritis
排除标准
- •patients with a history of GI surgery
- •advanced gastric carcinoma or any other malignancy in the GI tract
- •acute upper GI bleeding
- •patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function
- •patients refused to provide informed consent
研究组 & 干预措施
Cresyl violet
干预措施: Cresyl violet (Diagnostic Test)
结局指标
主要结局
feasibility of CV for identifying GIM
时间窗: 1 month
ratio of pCLE failure to visualize the cellular and subcellular structures
newly pCLE criteria with CV application for GIM
时间窗: 1 month
ratio of diagnostic agreement between pCLE using CV and histopathological results
次要结局
未报告次要终点
研究者
Yanqing Li
vice president of Qilu Hospital
Shandong University