Acute biliary Pancreatitis: early Endoscopic retrograde cholangiography plus sphincterotomy versus Conservative treatment (APEC trial)

Conditions

Acute biliary pancreatitis Digestive System Biliary acute pancreatitis

Schepers NJ, Hallensleben NDL, Besselink MG, Anten MGF, Bollen TL, da Costa DW, van Delft F, van Dijk SM, van Dullemen HM, Dijkgraaf MGW, van Eijck CHJ, Erkelens GW, Erler NS, Fockens P, van Geenen EJM, van Grinsven J, Hollemans RA, van Hooft JE, van der Hulst RWM, Jansen JM, Kubben FJGM, Kuiken SD, Laheij RJF, Quispel R, de Ridder RJJ, Rijk MCM, Römkens TEH, Ruigrok CHM, Schoon EJ, Schwartz MP, Smeets XJNM, Spanier BWM, Tan ACITL, Thijs WJ, Timmer R, Venneman NG, Verdonk RC, Vleggaar FP, van de Vrie W, Witteman BJ, van Santvoort HC, Bakker OJ, Bruno MJ, Dutch Pancreatitis Study Group.

2020-07-0195 citations

10.1016/s0140-6736(20)30539-0

Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial.

Schepers NJ, Bakker OJ, Besselink MG, Bollen TL, Dijkgraaf MG, van Eijck CH, Fockens P, van Geenen EJ, van Grinsven J, Hallensleben ND, Hansen BE, van Santvoort HC, Timmer R, Anten MP, Bolwerk CJ, van Delft F, van Dullemen HM, Erkelens GW, van Hooft JE, Laheij R, van der Hulst RW, Jansen JM, Kubben FJ, Kuiken SD, Perk LE, de Ridder RJ, Rijk MC, Römkens TE, Schoon EJ, Schwartz MP, Spanier BW, Tan AC, Thijs WJ, Venneman NG, Vleggaar FP, van de Vrie W, Witteman BJ, Gooszen HG, Bruno MJ, Dutch Pancreatitis Study Group.

2016-01-0522 citations

10.1186/s13063-015-1132-0

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. Int

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed