ISRCTN97372133Completed未知
Acute biliary Pancreatitis: early Endoscopic retrograde cholangiography plus sphincterotomy versus Conservative treatment (APEC trial): a randomized, superiority, assessor-blinded multicenter trial
Erasmus Medical Center (Netherlands)0 sites232 target enrollmentStarted: December 17, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 232
Study Overview
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)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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