Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,600
- 试验地点
- 6
- 主要终点
- Post-ERCP Pancreatitis
研究概览
简要总结
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing diagnostic or therapeutic ERCP.
排除标准
- •Unwillingness or inability to consent for the study;
- •Age < 18 years old;
- •Intrauterine pregnancy;
- •Breastfeeding mother;
- •Standard contraindications to ERCP;
- •Allergy to NSAIDs;
- •Received NSAIDs in prior 7 days;
- •Renal failure (Cr >1.4mg/dl=120umol/l);
- •Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;
- •Acute pancreatitis within 72 hours;
- •Known pancreatic head mass;
- •Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;
- •ERCP for biliary stent removal or exchange without anticipated pancreatogram;
- •Known active cardiovascular or cerebrovascular disease.
- •Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;
研究组 & 干预措施
Pre-ERCP group
Pre-ERCP rectal Indomethacin in all patients.
干预措施: Pre-ERCP rectal Indomethacin (Drug)
Post-ERCP group
Post-ERCP rectal Indomethacin in high-risk patients.
干预措施: Post-operational Rectal Indomethacin (Drug)
结局指标
主要结局
Post-ERCP Pancreatitis
时间窗: 30 days
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.
次要结局
- Moderate-to-severe Pancreatitis(30 days)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China