The Efficacy of Probe-based Confocal Laser Endomicroscopy in Staging OLGIM
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- the sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).
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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).
时间窗: 6 months
the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).
时间窗: 6 months
次要结局
- the of sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).(6 months)
- the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).(6 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University