Acute biliary Pancreatits: early ERC plus sphincterotomy versus Conservative treatment: the APEC trial, a randomized, superiority, assessor-blinded multicenter trial.
- Conditions
- Biliary pancreatitis / galstone induced acute inflammation of the pancreas100156741000460610017998
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 310
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of a composite endpoint of mortality and severe complications.<br /><br><br /><br>Major Complications are considered as (for definitions see protocol Appendix<br /><br>Table 3):<br /><br>- organ failure<br /><br>- pancreatic necrosis<br /><br>- bacteremia<br /><br>- cholangitis<br /><br>- pneumonia<br /><br>- exocrine and/ or endocrine pancreatic insufficiency</p><br>
- Secondary Outcome Measures
Name Time Method <p>Incidence of all individual components of the primary endpoint, length of<br /><br>hospital stay, new onset intensive care admission, length of intensive care<br /><br>stay, respiratory complications, cholangitis during admission, ERC-related<br /><br>complications, number of endoscopic, radiological and operative (re-)<br /><br>interventions, readmission for biliary events, difficulty of cholecystectomy<br /><br>and cost-effectiveness with direct medical and non-medical and indirect costs. </p><br>