Acute biliary Pancreatits: early ERC plus sphincterotomy versus Conservative treatment: the APEC trial, a randomized, superiority, assessor-blinded multicenter trial. - APEC trial

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 310 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Acute pancreatitis, defined as the presence of at least 2 out of the following 3 criteria:
•- upper abdominal pain
•- serum amylase and/ or lipase concentration >3 times the upper limit of normal
•- signs of pancreatitis on CT or MR
•2. Predicted severe course of the acute pancreatitis based on either one of the following positieve scores:
•- CRP >150mg/L
•- Imrie score * 3
•- APACHE II score * 8
•3. High probability acute biliary pancreatitis: see criterion 1 and at least one of the following criteria:
•- gallstones and/ or biliary sludge on imaging (US, CT of MR)
•- a dilated common bile duct on imaging (US, CT of MR) defined as >8mm in patients * 75 years or >10mm in patients >75 years
•- ALAT > two times upper limit of normal
•4. ERC can be performed within 24 hours after admission, but no more than 72 hours after the start of symtoms
•5. Age >18 year old
•6. Written informed consent
•7. In case of a previous episode of necrotizing pancreatitis, patient should be fully recovered (confirmed on imaging)

•1. Cholangitis
•2. Acute pancreatitis due to other causes such as alcohol abuse (either chronic or binge drinking), metabolic causes, medication, trauma, etc.
•3. Pregnancy
•4. Previous precut sphincterotomy and/ or ES
•5. INR that cannot be corrected with co-fact or FFP below 1.5
•6. Chronic pancreatitis

发起方