NCT02930616Unknown4 期
A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study
Shandong University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.
研究概览
简要总结
Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40 years or older with Helicobacter pylori infection;
- •Histologically verified GIM, atrophic gastritis or dysplasia.
排除标准
- •Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- •Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;
- •Pregnancy or breastfeeding;
- •Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
结局指标
主要结局
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.
时间窗: 9 months
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE.
时间窗: 9 months
次要结局
- the overall detection rate of GIM by WLE.(9 months)
- the overall detection rate of GIM by pCLE.(9 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University
研究点 (1)
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