Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- a fatty meal in the study group and normal saline in control group
研究概览
简要总结
This study is to determine if a fatty meal would improve the ERCP procedure.
详细描述
A fatty meal is a potent stimulator of cholecystikinin (CCK) in human body. The biological effect of CCK is increasing bile secretion and relaxing the sphincter of Oddi. Theoretically, a fatty meal should facilitate the effect on cannulation at ERCP. If a fatty meal can make the major papilla cannulation easier, it may significantly shorten the procedure time for ERCP and even decrease complications of the procedure, since the complication rate of post-ERCP is positively related to the time of the procedure.
Comparison: Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, 18 years and older, who are scheduled for ERCP at Emory University Hospital and signed consent before the procedure.
排除标准
- •Patients with a known allergy to milk or those who choose not to sign the consent.
结局指标
主要结局
a fatty meal in the study group and normal saline in control group
时间窗: the procedure time for ERCP
次要结局
- follow up within 3 days for complication with relation to the cannulation time(within 3 days)
研究者
Dr. Qiang Cai MD/PhD
Professor
Emory University