Conventional Fluorescein Sodium Dosage o.1ml/kg Compared With a Lower Fluorescein Sodium Dosage o.02ml/kg for the Detection of Gastric Intestinal Metaplasia in a High Risk Population: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis
研究概览
简要总结
The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.
详细描述
Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended.
This study aims to compare the diagnostic yield of gastric intestinal metaplasia from two different fluorescein sodium dosage and assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.
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
- Double (Participant, Investigator)
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
- •patients with dyspeptic symptoms and aged 40 years or older
- •or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- •or patients with family history of gastric cancer
排除标准
- •presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- •presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- •inability to provide informed consent
研究组 & 干预措施
Group 1
lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia
干预措施: lower fluorescein sodium dosage 0.02ml/kg (Drug)
Group 2
conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia
干预措施: conventional fluorescein sodium dosage 0.1ml/kg (Drug)
结局指标
主要结局
Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis
时间窗: six months
Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis
时间窗: six months
次要结局
未报告次要终点
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University