A Multicenter Randomized Controlled Trial of Ice Cold Water Flushing of the Ampulla After Endoscopic Sphincterotomy to Reduce Post-ERCP Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 主要终点
- Assess whether ice cold water flushing of the ampulla after ERCP reduces incidence of post ERCP pancreatitis compared to no flushing.
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential diagnostic and therapeutic tool used to manage diseases of the pancreatic and biliary systems. During the procedure, an upper endoscope is used to reach the major duodenal papilla, and a contrast material is injected into the ducts for radiologic imaging. In an endoscopic sphincterotomy, a specialized knife cuts the biliary sphincter to treat papilla conditions or facilitate therapeutic interventions.
The most common complication following an ERCP is pancreatitis, carrying an incidence rate of 3.5% to 9.7%. Standard preventive strategies currently include careful patient selection, rectal administration of NSAIDs (like indomethacin or diclofenac), aggressive intravenous hydration, and pancreatic stent placement.
The Innovation: Flushing the ampulla with ice-cold water after a sphincterotomy is a safe,easy, and cost-effective evolving intervention. While initial data demonstrates its safety,there is a clear deficiency in multicenter randomized trials assessing its overall clinical effectiveness, and no such studies have been conducted in the Gulf region. The primary goal of this study is to evaluate the effectiveness of ice-cold water flushing ofthe ampulla after endoscopic sphincterotomy in reducing the incidence of post-ERCP pancreatitis.
详细描述
This is a multicenter, randomized, controlled trial representing the population of Oman. A total of 210 adult patients (aged 18 and older) undergoing endoscopic sphincterotomy will be randomly assigned in a 1:1 ratio (105 patients per group) using stratified block randomization.The active group will receive a 250 mL ice-cold water flush of theampulla following sphincterotomy, while the control group will receive standard care without the flush.All adults (aged 18 years old and above) scheduled for an endoscopic sphincterotomy at the participating hospitals will be included. Patients with missing data, acute or chronic pancreatitis, pancreatic cancer, or those unable to provide informed consent will be excluded . Data will be prospectively retrieved from electronic hospital information systems (Trackcare at SQUH; AL-Shifa-3 at RH and NH) via printed data sheets. The results of this pioneering regional study are expected to provoke a shift in standard ERCP practices, successfully lowering patient complication rates and shortening hospital stays. Furthermore, it will build the first dedicated database from the Gulf region to drive future meta-analyses and advance advanced gastrointestinal research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (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
- •All adults (agesld 18 years old) scheduled for an endoscopic sphincterotomy at the participating hospitals.
排除标准
- •Patients with missing data, acute or chronic pancreatitis, pancreatic cancer, or those unable to provide informed consent.
结局指标
主要结局
Assess whether ice cold water flushing of the ampulla after ERCP reduces incidence of post ERCP pancreatitis compared to no flushing.
时间窗: 30 days
The primary goal of this study is to evaluate the effectiveness of ice-cold water flushing ofthe ampulla after endoscopic sphincterotomy in reducing the incidence of post-ERCP pancreatitis. Specific Objectives: * Procedure Efficiency: Compare the time required, success rate of cannulation, and rate of pancreatic stenting between patients who receive the ice-cold water flush and those who do not. * Complication Rates: Contrast post-sphincterotomy complications and the specific severity of post-procedure pancreatitis between the two groups. * Recovery and Burden: Compare the total length of hospital stay and the frequency of hospital revisits within 4 weeks post-procedure.
次要结局
未报告次要终点