CTRI/2014/11/005191招募中未知
A Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis in High Risk Patients (INDIEH) - INDIEH
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 948
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Major inclusion criteria (If patients meet at least 1 of the criteria)
- •1. History of PEP
- •2. Pancreatic sphincterotomy
- •3. Pre-cut sphincterotomy
- •4. Difficult cannulation (more than 5 attempts or more than 10 minutes to cannulate)
- •5. Failed cannulation
- •6. Pneumatic dilation of an intact sphincter
- •7. Sphincter of Oddi dysfunction of Type I or Type II.
- •Minor inclusion criteria (If patients meet at least 2 of the criteria)
- •1. Age less than 50 and Female gender
- •2. History of acute pancreatitis (at least 2 episodes)
- •3. Greater than or equal to 3 pancreatic injections (with at least 1 injection in tail)
- •4. Pancreatic acinarization
- •5. Pancreatic Brush Cytology
排除标准
- •1.Unwillingness or inability to consent for the study
- •2.Age less than 18 years
- •3.Intrauterine pregnancy
- •4.Breastfeeding mother
- •5.Standard contraindications to ERCP
- •6.Allergy / hypersensitivity to aspirin or NSAIDs or epinephrine
- •7.Chronic renal disease (Cr greater than 1.8)
- •8.Active or recent (within 4 weeks) gastrointestinal hemorrhage
- •9.Acute pancreatitis (lipase peak) within 72 hours
- •10.Known chronic calcific pancreatitis
- •11.Pancreatic head mass
- •12.Receiving pancreatic duct stent placement for any indication
- •13.Procedure performed on major papilla/ventral pancreatic duct in patients with pancreas divisum
- •14.ERCP for pancreatic/biliary stent removal or exchange without anticipated pancreatogram
- •15.Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
- •16.Anticipated inability to follow protocol
- •17.Sphincter of Oddi dysfunction of Type III
研究者
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