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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Nicolien J. Schepers, Olaf J. Bakker, Marc G. H. Besselink, Thomas L. Bollen, Marcel G. W. Dijkgraaf, Casper H. J. van Eijck, Paul Fockens, Erwin J. M. van Geenen, Janneke van Grinsven, Nora D. L. Hallensleben, Bettina E. Hansen, Hjalmar C. van Santvoort, Robin Timmer, Marie-Paule G. F. Anten, Clemens J. M. Bolwerk, Foke van Delft, Hendrik M. van Dullemen, G. Willemien Erkelens, Jeanin E. van Hooft, Robert Laheij, René W. M. van der Hulst, Jeroen M. Jansen, Frank J. G. M. Kubben, Sjoerd D. Kuiken, Lars E. Perk, Rogier J. J. de Ridder, Marno C. M. Rijk, Tessa E. H. Römkens, Erik J. Schoon, Matthijs P. Schwartz, B. W. Marcel Spanier, Adriaan C. I. T. L. Tan, Willem J. Thijs, Niels G. Venneman, Frank P. Vleggaar, Wim van de Vrie, Ben J. Witteman, Hein G. Gooszen, Marco J. Bruno, for the Dutch Pancreatitis Study Group

Published in: Trials | Issue 1/2016

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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)
Appendix
Available only for authorised users
Literature
1.
2.
3.
4.
Opie EL. The aetiology of acute haemorrhagic pancreatitis. Bull Johns Hop Hosp. 1901;xii:182–8.
5.
Lerch MM, Saluja AK, Runzi M, Dawra R, Saluja M, Steer ML. Pancreatic duct obstruction triggers acute necrotizing pancreatitis in the opossum. Gastroenterology. 1993;104:853–61.CrossRefPubMed
6.
7.
8.
Tse F, Yuan Y. Early routine endoscopic retrograde cholangiopancreatography strategy versus early conservative management strategy in acute gallstone pancreatitis. Cochrane Database Syst Rev. 2012;5:CD009779. doi:10.​1002/​14651858.​CD009779.​pub2.PubMed
9.
10.
11.
van Santvoort HC, Besselink MG, de Vries AC, Boermeester MA, Fischer K, Bollen TL, et al. Early endoscopic retrograde cholangiopancreatography in predicted severe acute biliary pancreatitis: a prospective multicenter study. Ann Surg. 2009;250:68–75. doi:10.​1097/​SLA.​0b013e3181a77bb4​.CrossRefPubMed
12.
Neoptolemos JP, Stonelake P, Radley S. Endoscopic sphincterotomy for acute pancreatitis. Hepatogastroenterology. 1993;40:550–5.PubMed
13.
Venneman NG, Renooij W, Rehfeld JF, VanBerge-Henegouwen GP, Go PM, Broeders IA, et al. Small gallstones, preserved gallbladder motility, and fast crystallization are associated with pancreatitis. Hepatology. 2005;41:738–46. doi:10.​1002/​hep.​20616.CrossRefPubMed
14.
15.
16.
Petrov MS, van Santvoort HC, Besselink MG, van der Heijden GJ, van Erpecum KJ, Gooszen HG. Early endoscopic retrograde cholangiopancreatography versus conservative management in acute biliary pancreatitis without cholangitis: a meta-analysis of randomized trials. Ann Surg. 2008;247:250–7. doi:10.​1097/​SLA.​0b013e31815edddd​.CrossRefPubMed
17.
18.
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013;62:102–11. doi:10.​1136/​gutjnl-2012-302779.CrossRefPubMed
19.
Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985;13:818–29.CrossRefPubMed
20.
Corfield AP, Cooper MJ, Williamson RC, Mayer AD, McMahon MJ, Dickson AP, et al. Prediction of severity in acute pancreatitis: prospective comparison of three prognostic indices. Lancet. 1985;2:403–7.CrossRefPubMed
21.
Neoptolemos JP, Kemppainen EA, Mayer JM, Fitzpatrick JM, Raraty MG, Slavin J, et al. Early prediction of severity in acute pancreatitis by urinary trypsinogen activation peptide: a multicentre study. Lancet. 2000;355:1955–60.CrossRefPubMed
22.
Werner J, Hartwig W, Uhl W, Muller C, Buchler MW. Useful markers for predicting severity and monitoring progression of acute pancreatitis. Pancreatology. 2003;3:115–27.CrossRefPubMed
23.
Ammori BJ, Boreham B, Lewis P, Roberts SA. The biochemical detection of biliary etiology of acute pancreatitis on admission: a revisit in the modern era of biliary imaging. Pancreas. 2003;26:e32–5.CrossRefPubMed
24.
25.
26.
Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83.CrossRefPubMed
27.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L). Qual Life Res Int J Qual Life Asp Treat Care Rehab. 2011;20:1727–36. doi:10.​1007/​s11136-011-9903-x.CrossRef
28.
Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996;22:707–10.CrossRefPubMed
29.
Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995;23:1638–52.CrossRefPubMed
30.
Lamers LM, Stalmeier PF, McDonnell J, Krabbe PF, van Busschbach JJ. Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff. Ned Tijdschr Geneeskd. 2005;149:1574–8.PubMed
31.
Hakkaart-van Roijen LTS, Bouwmans CAM: Handleiding voor kostenonderzoek, methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. College voor zorgverzekeringen. Geactualiseerde versie 2010. [Manual for cost analysis in health care; Dutch]. Rotterdam, the Netherlands; 2011:2010.
32.
33.
Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer. 1976;34:585–612.CrossRefPubMedPubMedCentral
34.
Acosta JM, Rubio Galli OM, Rossi R, Chinellato AV, Pellegrini CA. Effect of duration of ampullary gallstone obstruction on severity of lesions of acute pancreatitis. J Am Coll Surg. 1997;184:499–505.PubMed
35.
Runzi M, Saluja A, Lerch MM, Dawra R, Nishino H, Steer ML. Early ductal decompression prevents the progression of biliary pancreatitis: an experimental study in the opossum. Gastroenterology. 1993;105:157–64.CrossRefPubMed
36.
Bakker OJ, van Santvoort H, Besselink MG, Boermeester MA, van Eijck C, Dejong K, et al. Extrapancreatic necrosis without pancreatic parenchymal necrosis: a separate entity in necrotising pancreatitis? Gut. 2013;62:1475–80. doi:10.​1136/​gutjnl-2012-302870.CrossRefPubMed
37.
van Santvoort HC, Bakker OJ, Besselink MG, Bollen TL, Fischer K, Nieuwenhuijs VB, et al. Prediction of common bile duct stones in the earliest stages of acute biliary pancreatitis. Endoscopy. 2011;43:8–13. doi:10.​1055/​s-0030-1255866.CrossRefPubMed
38.
Giljaca V, Gurusamy KS, Takwoingi Y, Higgie D, Poropat G, Stimac D, et al. Endoscopic ultrasound versus magnetic resonance cholangiopancreatography for common bile duct stones. Cochrane Database Syst Rev. 2015;2:CD011549. doi:10.​1002/​14651858.​CD011549.PubMed
39.
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991;37:383–93.CrossRefPubMed
40.
Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000; 21:1502–13. doi:10.​1053/​euhj.​2000.​2305.
41.
Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000;36:959–69.CrossRefPubMed
42.
Schneider A, Lohr JM, Singer MV. The M-ANNHEIM classification of chronic pancreatitis: introduction of a unifying classification system based on a review of previous classifications of the disease. J Gastroenterol. 2007;42:101–19. doi:10.​1007/​s00535-006-1945-4.CrossRefPubMed
43.
Moher D, Schulz KF, Altman DG, Group C. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. J Am Podiatr Med Assoc. 2001;91:437–42.CrossRefPubMed
Metadata
Title
Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial
Authors
Nicolien J. Schepers
Olaf J. Bakker
Marc G. H. Besselink
Thomas L. Bollen
Marcel G. W. Dijkgraaf
Casper H. J. van Eijck
Paul Fockens
Erwin J. M. van Geenen
Janneke van Grinsven
Nora D. L. Hallensleben
Bettina E. Hansen
Hjalmar C. van Santvoort
Robin Timmer
Marie-Paule G. F. Anten
Clemens J. M. Bolwerk
Foke van Delft
Hendrik M. van Dullemen
G. Willemien Erkelens
Jeanin E. van Hooft
Robert Laheij
René W. M. van der Hulst
Jeroen M. Jansen
Frank J. G. M. Kubben
Sjoerd D. Kuiken
Lars E. Perk
Rogier J. J. de Ridder
Marno C. M. Rijk
Tessa E. H. Römkens
Erik J. Schoon
Matthijs P. Schwartz
B. W. Marcel Spanier
Adriaan C. I. T. L. Tan
Willem J. Thijs
Niels G. Venneman
Frank P. Vleggaar
Wim van de Vrie
Ben J. Witteman
Hein G. Gooszen
Marco J. Bruno
for the Dutch Pancreatitis Study Group
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-1132-0

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