A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 602
- 试验地点
- 4
- 主要终点
- Post-ERCP Pancreatitis
研究概览
简要总结
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.
Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.
详细描述
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.
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 (Participant, Care Provider, Investigator)
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
- •Included patients are those undergoing ERCP and have one of the following:
- •Clinical suspicion of sphincter of Oddi dysfunction
- •History of post-ERCP pancreatitis (at least one episode)
- •Pancreatic sphincterotomy
- •Pre-cut (access) sphincterotomy
- •> 8 cannulation attempts
- •Pneumatic dilation of intact biliary sphincter
- •Ampullectomy
- •or at least 2 of the following:
- •Age < 50 years old & female gender
- •History of recurrent pancreatitis (at least 2 episodes)
- •≥3 pancreatic injections, with at least one injection to tail
- •Pancreatic acinarization
- •Pancreatic brush cytology
排除标准
- •Unwillingness or inability to consent for the study
- •Age < 18 years
- •Intrauterine pregnancy
- •Breast feeding mother
- •Standard contraindications to ERCP
- •Allergy to Aspirin or NSAIDs
- •Renal failure (Cr > 1.4)
- •Active or recent (within 4 weeks) gastrointestinal hemorrhage
- •Acute pancreatitis (lipase peak) within 72 hours
- •Known chronic calcific pancreatitis
- •Pancreatic head malignancy
- •Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
- •ERCP for biliary stent removal or exchange without anticipated pancreatogram
- •Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
- •Anticipated inability to follow protocol
- •Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis
研究组 & 干预措施
1
Indomethacin suppository
干预措施: Indomethacin (Drug)
2
Placebo suppository
干预措施: Placebo suppositories (Other)
结局指标
主要结局
Post-ERCP Pancreatitis
时间窗: 5 days
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.
次要结局
未报告次要终点
研究者
Badih Joseph Elmunzer
Assistant Professor, Gastroenterology
University of Michigan