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

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; Rene 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. Romkens; 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

doi:10.1186/s13063-015-1132-0

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

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 LaheijRene 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. Romkens, 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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Article number	5
Journal	Trials
Volume	17
DOIs	https://doi.org/10.1186/s13063-015-1132-0
Publication status	Published - 5 Jan 2016

Keywords

Acute pancreatitis
Treatment
Endoscopy
Pancreas
ERCP
ERC

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Cite this

Schepers, N. J., Bakker, O. J., Besselink, M. G. H., Bollen, T. L., Dijkgraaf, M. G. W., van Eijck, C. H. J., Fockens, P., van Geenen, E. J. M., van Grinsven, J., Hallensleben, N. D. L., Hansen, B. E., van Santvoort, H. C., Timmer, R., Anten, M-P. G. F., Bolwerk, C. J. M., van Delft, F., van Dullemen, H. M., Erkelens, G. W., van Hooft, J. E., ... Bruno, M. J. (2016). Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial. Trials, 17, Article 5. https://doi.org/10.1186/s13063-015-1132-0

@article{8de560263ce94df1a5d7ac0acce5ea59,

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

abstract = "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.",

keywords = "Acute pancreatitis, Treatment, Endoscopy, Pancreas, ERCP, ERC",

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

year = "2016",

month = jan,

day = "5",

doi = "10.1186/s13063-015-1132-0",

language = "English",

volume = "17",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

}

Schepers, NJ, Bakker, OJ, Besselink, MGH, Bollen, TL, Dijkgraaf, MGW, van Eijck, CHJ, Fockens, P, van Geenen, EJM, van Grinsven, J, Hallensleben, NDL, Hansen, BE, van Santvoort, HC, Timmer, R, Anten, M-PGF, Bolwerk, CJM, van Delft, F, van Dullemen, HM, Erkelens, GW, van Hooft, JE, Laheij, R, van der Hulst, RWM, Jansen, JM, Kubben, FJGM, Kuiken, SD, Perk, LE, de Ridder, RJJ, Rijk, MCM, Romkens, TEH, Schoon, EJ, Schwartz, MP, Spanier, BWM, Tan, ACITL, Thijs, WJ, Venneman, NG, Vleggaar, FP, van de Vrie, W, Witteman, BJ, Gooszen, HG & Bruno, MJ 2016, 'Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial', Trials, vol. 17, 5. https://doi.org/10.1186/s13063-015-1132-0

TY - JOUR

T1 - Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial

AU - Schepers, Nicolien J.

AU - Bakker, Olaf J.

AU - Besselink, Marc G. H.

AU - Bollen, Thomas L.

AU - Dijkgraaf, Marcel G. W.

AU - van Eijck, Casper H. J.

AU - Fockens, Paul

AU - van Geenen, Erwin J. M.

AU - van Grinsven, Janneke

AU - Hallensleben, Nora D. L.

AU - Hansen, Bettina E.

AU - van Santvoort, Hjalmar C.

AU - Timmer, Robin

AU - Anten, Marie-Paule G. F.

AU - Bolwerk, Clemens J. M.

AU - van Delft, Foke

AU - van Dullemen, Hendrik M.

AU - Erkelens, G. Willemien

AU - van Hooft, Jeanin E.

AU - Laheij, Robert

AU - van der Hulst, Rene W. M.

AU - Jansen, Jeroen M.

AU - Kubben, Frank J. G. M.

AU - Kuiken, Sjoerd D.

AU - Perk, Lars E.

AU - de Ridder, Rogier J. J.

AU - Rijk, Marno C. M.

AU - Romkens, Tessa E. H.

AU - Schoon, Erik J.

AU - Schwartz, Matthijs P.

AU - Spanier, B. W. Marcel

AU - Tan, Adriaan C. I. T. L.

AU - Thijs, Willem J.

AU - Venneman, Niels G.

AU - Vleggaar, Frank P.

AU - van de Vrie, Wim

AU - Witteman, Ben J.

AU - Gooszen, Hein G.

AU - Bruno, Marco J.

PY - 2016/1/5

Y1 - 2016/1/5

N2 - 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.

AB - 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.

KW - Acute pancreatitis

KW - Treatment

KW - Endoscopy

KW - Pancreas

KW - ERCP

KW - ERC

U2 - 10.1186/s13063-015-1132-0

DO - 10.1186/s13063-015-1132-0

M3 - Article

C2 - 26729193

SN - 1745-6215

VL - 17

JO - Trials

JF - Trials

M1 - 5

ER -