Abstract

Background

Acute pancreatitis is mostly caused by gallstones or sludge. Early decompression of the biliary tree by endoscopic retrograde cholangiography (ERC) with sphincterotomy may improve outcome in these patients. Whereas current guidelines recommend early ERC in patients with concomitant cholangitis, early ERC is not recommended in patients with mild biliary pancreatitis. Evidence on the role of routine early ERC with endoscopic sphincterotomy in patients without cholangitis but with biliary pancreatitis at high risk for complications is lacking. We hypothesize that early ERC with sphincterotomy improves outcome in these patients.

Methods/Design

The APEC trial is a randomized controlled, parallel group, superiority multicenter trial. Within 24 hours after presentation to the emergency department, patients with biliary pancreatitis without cholangitis and at high risk for complications, based on an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 8 or greater, Modified Glasgow score of 3 or greater, or serum C-reactive protein above 150 mg/L, will be randomized. In 27 hospitals of the Dutch Pancreatitis Study Group, 232 patients will be allocated to early ERC with sphincterotomy or to conservative treatment. The primary endpoint is a composite of major complications (that is, organ failure, pancreatic necrosis, pneumonia, bacteremia, cholangitis, pancreatic endocrine, or exocrine insufficiency) or death within 180 days after randomization. Secondary endpoints include ERC-related complications, infected necrotizing pancreatitis, length of hospital stay and an economical evaluation.

Discussion

The APEC trial investigates whether an early ERC with sphincterotomy reduces the composite endpoint of major complications or death compared with conservative treatment in patients with biliary pancreatitis at high risk of complications.

Trial registration

Current Controlled Trials ISRCTN97372133 (date registration: 17-12-2012)

Details

Title
Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial
Author
Schepers, Nicolien J. 1 ; Bakker, Olaf J. 2 ; Besselink, Marc G. H. 3 ; Bollen, Thomas L. 4 ; Dijkgraaf, Marcel G. W. 5 ; van Eijck, Casper H. J. 6 ; Fockens, Paul 7 ; van Geenen, Erwin J. M. 8 ; van Grinsven, Janneke 9 ; Hallensleben, Nora D. L. 10 ; Hansen, Bettina E. 11 ; van Santvoort, Hjalmar C. 12 ; Timmer, Robin 11 ; Anten, Marie-Paule G. F. 13 ; Bolwerk, Clemens J. M. 14 ; van Delft, Foke 15 ; van Dullemen, Hendrik M. 16 ; Erkelens, G. Willemien 17 ; van Hooft, Jeanin E. 7 ; Laheij, Robert 18 ; van der Hulst, René W. M. 19 ; Jansen, Jeroen M. 20 ; Kubben, Frank J. G. M. 21 ; Kuiken, Sjoerd D. 22 ; Perk, Lars E. 23 ; de Ridder, Rogier J. J. 24 ; Rijk, Marno C. M. 25 ; Römkens, Tessa E. H. 26 ; Schoon, Erik J. 27 ; Schwartz, Matthijs P. 28 ; Spanier, B. W. Marcel 29 ; Tan, Adriaan C. I. T. L. 30 ; Thijs, Willem J. 31 ; Venneman, Niels G. 32 ; Vleggaar, Frank P. 33 ; van de Vrie, Wim 34 ; Witteman, Ben J. 35 ; Gooszen, Hein G. 36 ; Bruno, Marco J. 11 

1  Erasmus Medical Center, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands (GRID:grid.5645.2) (ISNI:000000040459992X); St Antonius Hospital, Department of Gastroenterology and Hepatology, Nieuwegein, The Netherlands (GRID:grid.415960.f) (ISNI:0000000406221269) 
2  University Medical Center Utrecht, Department of Surgery, Utrecht, The Netherlands (GRID:grid.7692.a) (ISNI:0000000090126352) 
3  Academic Medical Center University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands (GRID:grid.5650.6) (ISNI:0000000404654431) 
4  St Antonius Hospital, Department of Radiology, Nieuwegein, The Netherlands (GRID:grid.415960.f) (ISNI:0000000406221269) 
5  Clinical Research Unit, Academic Medical Center University of Amsterdam, Amsterdam, The Netherlands (GRID:grid.5650.6) (ISNI:0000000404654431) 
6  Erasmus Medical Center, Department of Surgery, Rotterdam, The Netherlands (GRID:grid.5645.2) (ISNI:000000040459992X) 
7  Academic Medical Center University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands (GRID:grid.5650.6) (ISNI:0000000404654431) 
8  Radboud University Nijmegen Medical Centre, Department of Gastroenterology and Hepatology, Nijmegen, The Netherlands (GRID:grid.10417.33) (ISNI:0000000404449382) 
9  Academic Medical Center University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands (GRID:grid.5650.6) (ISNI:0000000404654431); Academic Medical Center University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands (GRID:grid.5650.6) (ISNI:0000000404654431) 
10  Erasmus Medical Center, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands (GRID:grid.5645.2) (ISNI:000000040459992X); St Antonius Hospital, Department of Surgery, Nieuwegein, The Netherlands (GRID:grid.415960.f) (ISNI:0000000406221269) 
11  Erasmus Medical Center, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands (GRID:grid.5645.2) (ISNI:000000040459992X) 
12  St Antonius Hospital, Department of Surgery, Nieuwegein, The Netherlands (GRID:grid.415960.f) (ISNI:0000000406221269) 
13  Sint Franciscus Gasthuis, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands (GRID:grid.461048.f) (ISNI:0000000404599858) 
14  Reinier de Graaf Hospital, Department of Gastroenterology and Hepatology, Delft, The Netherlands (GRID:grid.415868.6) (ISNI:0000000406245690) 
15  VU University Medical Center Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands (GRID:grid.16872.3a) (ISNI:000000040435165X) 
16  University Medical Center Groningen, Department of Gastroenterology and Hepatology, Groningen, The Netherlands (GRID:grid.4494.d) (ISNI:0000000095584598) 
17  Gelre Hospital, Department of Gastroenterology and Hepatology, Apeldoorn, The Netherlands (GRID:grid.415355.3) (ISNI:0000000403704214) 
18  St. Elisabeth Hospital, Department of Gastroenterology and Hepatology, Tilburg, The Netherlands (GRID:grid.416373.4) 
19  Department of Gastroenterology and Hepatology, Kennemer Gasthuis, Haarlem, The Netherlands (GRID:grid.465804.b) (ISNI:0000000404075923) 
20  Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands (GRID:grid.440209.b) 
21  Maasstad Hospital, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands (GRID:grid.416213.3) (ISNI:0000000404600556) 
22  Sint Lucas Andreas Hospital, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands (GRID:grid.415973.d) (ISNI:0000000403693324) 
23  Medical Center Haaglanden, Department of Gastroenterology and Hepatology, CK Den Haag, The Netherlands (GRID:grid.414842.f) (ISNI:0000000403956796) 
24  Maastricht University Medical Center, Department of Gastroenterology and Hepatology, Maastricht, The Netherlands (GRID:grid.412966.e) (ISNI:0000 0004 0480 1382) 
25  Amphia Hospital, Department of Gastroenterology and Hepatology, Breda, The Netherlands (GRID:grid.413711.1) 
26  Jeroen Bosch Hospital, Department of Gastroenterology and Hepatology, ME ‘s-Hertogenbosch, The Netherlands (GRID:grid.413508.b) (ISNI:0000000405019798) 
27  Catharina Hospital, Department of Gastroenterology and Hepatology, Eindhoven, The Netherlands (GRID:grid.413532.2) (ISNI:0000000403988384) 
28  Meander Medical Center, Department of Gastroenterology and Hepatology, Amersfoort, The Netherlands (GRID:grid.414725.1) (ISNI:0000000403688146) 
29  Rijnstate Hospital, Department of Gastroenterology and Hepatology, Arnhem, The Netherlands (GRID:grid.415930.a) 
30  Canisius-Wilhelmina Hospital, Department of Gastroenterology and Hepatology, Nijmegen, The Netherlands (GRID:grid.413327.0) (ISNI:0000000404449008) 
31  Martini Hospital, Department of Gastroenterology and Hepatology, Groningen, The Netherlands (GRID:grid.416468.9) (ISNI:0000000406319063) 
32  Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands (GRID:grid.415214.7) (ISNI:0000000403998347) 
33  University Medical Center Utrecht, Department of Gastroenterology and Hepatology, Utrecht, The Netherlands (GRID:grid.7692.a) (ISNI:0000000090126352) 
34  Albert Schweitzer Hospital, Department of Gastroenterology and Hepatology, Dordrecht, The Netherlands (GRID:grid.413972.a) (ISNI:000000040396792X) 
35  Hospital Gelderse Vallei Ede, Department of Gastroenterology and Hepatology, Ede, The Netherlands (GRID:grid.415351.7) (ISNI:0000 0004 0398 026X) 
36  Radboud University Nijmegen Medical Centre, Department of Operating Rooms - Evidence Based Surgery, Nijmegen, The Netherlands (GRID:grid.10417.33) (ISNI:0000000404449382) 
Pages
5
Publication year
2016
Publication date
Dec 2016
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-015-1132-0
ProQuest document ID
2795234184
Copyright
© Schepers et al. 2016. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.