Comparison of Confocal Laser Endomicroscopy With Standard Endoscopy for the Detection and Evaluation of Gastric Intestinal Metaplasia in a High Risk Population: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- the diagnostic yield of gastric intestinal metaplasia
研究概览
简要总结
The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.
详细描述
Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years old ≤ age < 80 years old
- •Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
- •Able to give informed consent.
排除标准
- •Esophageal, gastric or duodenal cancer or other malignancy
- •Known GIM or intraepithelial neoplasia in upper GI tract
- •Scheduled for endoscopic therapy
- •History of upper GI tract surgery
- •Reflux esophagitis or acute gastritis or peptic ulcers
- •Acute upper gastrointestinal bleeding
- •Coagulopathy or bleeding disorders
- •Allergy to fluorescein sodium
- •Pregnant or breast-feeding (for females)
- •Impaired renal function
结局指标
主要结局
the diagnostic yield of gastric intestinal metaplasia
时间窗: Seven months
次要结局
- the biopsy number needed in each group(Seven months)
研究者
Yanqing Li
Chief of the Department of Gastroenterolgoy, Qilu Hospital
Shandong University