EMILY: Endoscopic sphincterotoMy for delayIng choLecYstectomy in mild acute biliary pancreatitis

niversity of Pécs0 个研究点目标入组 89 人开始时间: 2018年11月20日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•1. Aged 18 years or older
•2. Diagnosis of acute pancreatitis, with at least 2 of the following symptoms:
•2.1. Upper abdominal pain
•2.2. Serum lipase three times higher than the upper limit of normal and characteristic findings for acute pancreatitis on imaging
•2.3. Serum amylase three times higher than the upper limit of normal and characteristic findings for acute pancreatitis on imaging
•3. Mild biliary pancreatitis (no pancreatic necrosis, no transient or persistent organ failure (>48 hours)) according to the revised Atlanta classification
•4. Any of the following 3 definitions of biliary pancreatitis:
•4.1. Diagnosis of gallstones or sludge on imaging
•4.2. Dilated common bile duct on ultrasound (>8 mm in patients aged 75 years old and under, or >10 mm in patients over 75 years old) with the absence of gallstones or sludge in the gallbladder
•4.3. Alanine aminotransferase level >2 times higher than normal values, with alanine aminotransferase levels greater than aspartate aminotransferase levels
•5. ERCP/ES either during the index admission or in the medical history without complication (added 01/02/2019)
•6. Signed written informed consent

•1. Poor physical status
•2. American Society of Anesthesiologists (ASA) class III in patients over 75 years old
•3. ASA class IV or V in patients 75 years old or younger
•4. Continuous alcohol abuse
•5. Chronic pancreatitis
•6. Pregnancy
•7. Previous sphincterotomy (removed 01/02/2019)
•8. Previous cholecystectomy

发起方

niversity of Pécs