NCT02515721Unknown不适用
Probe-based Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia,Intraepithelial Neoplasia,and Carcinoma:A Multicenter,Randomized,Controlled Trial
Shandong University1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer
研究概览
简要总结
Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan alone.
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
- Triple (Participant, 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
- •aged between 18 and 80;
- •patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia;
- •agree to give written informed consent.
排除标准
- •Patients with gastrectomy, acute GI bleeding, and known gastric neoplasia;
- •Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
- •Inability to provide informed consent
结局指标
主要结局
the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer
时间窗: 12 months
次要结局
- the biopsy number needed for diagnosis(12 months)
研究者
Yanqing Li
Chief of the department of Gastroenterology
Shandong University
研究点 (1)
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