A Randomized, Double-Blind, Prospective Trial of Oral Administration of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).
研究概览
简要总结
The purpose of this study is to determine if giving Aprepitant 4 hours before and for two days after ERCP decreases the risk of developing pancreatitis after ERCP.
详细描述
This study involves taking a drug Aprepitant by mouth 4 hours before the ERCP and once a day for two days after the ERCP, in an attempt to reduce the risk of pancreatitis caused by ERCP. Pancreatitis, or injury and inflammation of the pancreas, is the most common complication of ERCP and occurs in approximately 6 out of every 100 patients undergoing ERCP. It may result in pain and lead to hospitalization and, in some cases, a need for further procedures such as surgery.
Aprepitant is a medication that is currently used to prevent nausea and vomiting in some patients caused by chemotherapy for the treatment of cancer. It is also approved for the prevention of post-operative nausea and vomiting. There is theoretical evidence from animal studies that the way in which Aprepitant works in the body may prevent pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients selected for the study will be those undergoing ERCP who are at high risk for development of post-ERCP pancreatitis
- •patients expected to undergo a sphincterotomy
- •patients with suspected sphincter of oddi dysfunction
- •patients with a known history in the past of post-ERCP pancreatitis
- •patients less than 60 years of age
排除标准
- •active pancreatitis
- •if they are pregnant
- •known adverse reaction to aprepitant
研究组 & 干预措施
1
aprepitant
干预措施: aprepitant (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).
时间窗: 48 hours
次要结局
- Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis(48 hours post ERCP and 1 week post ERCP)
- Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis(7 days)