Acute biliary Pancreatitis: early Endoscopic retrograde cholangiography plus sphincterotomy versus Conservative treatment (APEC trial)
Not Applicable
Completed
- Conditions
- Acute biliary pancreatitisBiliary acute pancreatitisDigestive System
- Registration Number
- ISRCTN97372133
- Lead Sponsor
- Erasmus Medical Center (Netherlands)
- Brief Summary
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26729193 2020 results in https://pubmed.ncbi.nlm.nih.gov/32682482/ (added 21/07/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 232
Inclusion Criteria
1. Acute biliary pancreatitis
2. Predicted severe disease course
3. ERC with sphincterotomy can be performed within 24 hours after admission
4. Age > 18 years
5. Written informed consent
6. In case of a previous episode of necrotizing pancreatitis, patient should be fully recovered
Exclusion Criteria
1. Cholangitis
2. Acute pancreatitis due to other causes such as alcohol abuse, metabolic causes, medication, trauma, etc.
3. Previous (precut) sphincterotomy
4. Chronic pancreatitis
5. INR that cannot be corrected with co-fact or fresh frozen plasma below 1.5
6. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> A composite of severe morbidity and mortality occurring until 6 months after randomization.<br><br> Severe morbidity is defined as the occurrence of persistent single organ failure, necrotizing pancreatitis, bacteremia, cholangitis, pneumonia or exocrine or endocrine pancreatic insufficiency.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Individual components of the primary endpoint<br> 2. Length of hospital stay<br> 3. Need for of new intensive care admission<br> 4. Length of intensive care stay<br> 5. Respiratory complications<br> 6. ERC related complications<br> 7. Number of endoscopic, radiological and operative (re-)interventions<br> 8. Readmission for biliary events<br> 9. Difficulty of cholecystectomy<br> 10. Economical evaluation<br>