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21 March 2013
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| [ Print-friendly version ] |
| Acute biliary Pancreatitis: early Endoscopic retrograde cholangiography plus sphincterotomy versus Conservative treatment (APEC trial) |
| ISRCTN | ISRCTN97372133 |
| DOI | 10.1186/ISRCTN97372133 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Acute biliary Pancreatitis: early Endoscopic retrograde cholangiography plus sphincterotomy versus Conservative treatment (APEC trial) |
| Scientific title | Acute biliary Pancreatitis: early Endoscopic retrograde cholangiography plus sphincterotomy versus Conservative treatment (APEC trial): a randomized, superiority, assessor-blinded multicenter trial |
| Acronym | APEC |
| Serial number at source | N/A |
| Study hypothesis | We hypothesize that early endoscopic retrograde cholangiography (ERC) plus sphincterotomy improves the outcome of patients with acute biliary pancreatitis without cholangitis in whom the disease course is predicted to be severe. |
| Lay summary | Lay summary under review 2 |
| Ethics approval | Erasmus Medical Center Rotterdam Ethics Committee, 08 November 2012 ref: MEC-2012-357 |
| Study design | Randomized superiority assessor-blinded multicenter trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Acute biliary pancreatitis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2013 |
| Anticipated end date | 01/02/2015 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found at http://www.pancreatitis.nl/ |
| Target number of participants | 232 patients |
| Interventions |
The trial will be performed by the Dutch Pancreatitis Study Group. A total of 232 patients will be randomized in 25 participating centers of the Dutch Pancreatitis Study Group.
1. Intervention group: early (<24 hours of admission) ERC plus sphincterotomy. 2. Comparison group: conservative (expectative) management, delayed ERC when clinically indicated. The total duration of follow-up is until 6 months after randomization. |
| Primary outcome measure(s) |
A composite of severe morbidity and mortality occurring until 6 months after randomization.
Severe morbidity is defined as the occurrence of persistent single organ failure, necrotizing pancreatitis, bacteremia, cholangitis, pneumonia or exocrine or endocrine pancreatic insufficiency. |
| Secondary outcome measure(s) |
1. Individual components of the primary endpoint
2. Length of hospital stay 3. Need for of new intensive care admission 4. Length of intensive care stay 5. Respiratory complications 6. ERC related complications 7. Number of endoscopic, radiological and operative (re-)interventions 8. Readmission for biliary events 9. Difficulty of cholecystectomy 10. Economical evaluation |
| Sources of funding |
1. Fonds NutsOhra (Netherlands) ref: 1203-052
2. Pancreas Society (Alvleeskliervereniging) (Netherlands) 3. Erasmus Medical Center Rotterdam (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Prof M.J. Bruno |
| Address |
Erasmus Medical Center
Department of Gastroenterology and Hepatology s-Gravendijkwal 230 |
| City/town | Rotterdam |
| Zip/Postcode | 3015CE |
| Country | Netherlands |
| Tel | +31 (0)10 703 5946 |
| Fax | +31 (0)10 703 0352 |
| m.bruno@erasmusmc.nl | |
| Sponsor | Erasmus Medical Center (Netherlands) |
| Address |
Dutch Pancreatitis Study Group
Department of Gastroenterology and Hepatology s-Gravendijkwal 230 |
| City/town | Rotterdam |
| Zip/Postcode | 3015CE |
| Country | Netherlands |
| Tel | +31 (0)61 441 1960 |
| Fax | +31 (0)24 361 3834 |
| m.bruno@erasmusmc.nl | |
| Sponsor website: | http://www.erasmusmc.nl |
| Date applied | 13/11/2012 |
| Last edited | 17/12/2012 |
| Date ISRCTN assigned | 17/12/2012 |
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