Biliary pancreatitis / galstone induced acute inflammation of the pancreas
Conditions
Interventions
Intervention: Early (
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of a composite endpoint of mortality and severe complications. Major Complications are considered as (for definitions see protocol Appendix Table 3): - organ failure - pancreatic necrosis - bacteremia - cholangitis - pneumonia - exocrine and/ or endocrine pancreatic insufficiency | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of all individual components of the primary endpoint, length of hospital stay, new onset intensive care admission, length of intensive care stay, respiratory complications, cholangitis during admission, ERC-related complications, number of endoscopic, radiological and operative (re-) interventions, readmission for biliary events, difficulty of cholecystectomy and cost-effectiveness with direct medical and non-medical and indirect costs. | — |
Countries
Netherlands
Outcome results
None listed