Pancreatic stenting to prevent post-ERCP pancreatitis: a randomized multicenter trial

Abstract

Background and study aims Acute pancreatitis (AP) is one of the most common gastrointestinal disorders leading to hospitalization and the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP). Besides pharmaco-prophylaxis, pancreatic stenting has been demonstrated to protect from post-ERCP pancreatitis (PEP). However, it remains unclear which patients benefit from pancreatic stenting. We therefore hypothesized that in an unselected population, inadvertent cannulation of the pancreatic duct during first-time ERCP increases risk of PEP and that this risk can be significantly reduced by pancreatic stenting.

Patients and methods This study was a multicenter, prospective, randomized controlled trial conducted at four European centers. A total of 167 patients undergoing first-time ERCP were enrolled in this trial. In the case of inadvertent cannulation of the pancreatic duct, patients were randomly assigned to receive either a 5 French plastic pancreatic stent of various length or no routine prophylactic intervention for PEP.

Results A total of 167 patients were included in the final analysis. Prophylactic stent insertion significantly reduced the rate of PEP during first-time ERCP (odds ratio 0.43; 95% confidence interval 0.19 – 0.98; P = 0.04). The number needed to treat to prevent one case of PEP by prophylactic stent insertion after inadvertent cannulation of the pancreatic duct was 8.1 for the intention-to-treat population.

Conclusion In an unselected patient population, inadvertent cannulation of the pancreatic duct during first-time ERCP is associated with a high risk for PEP. This risk can be significantly reduced by prophylactic pancreatic stenting, which is a safe and feasible procedure.

• References

• 1 Peery AF, Crockett SD, Barritt AS. et al. Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States. Gastroenterology 2015; 149: 1731-1741
• 2 Phillip V, Steiner JM, Algul H. Early phase of acute pancreatitis: Assessment and management. World journal of gastrointestinal pathophysiology 2014; 5: 158-168
• 3 Talukdar R. Complications of ERCP. Best Pract Res Clin Gastroenterol 2016; 30: 793-805
• 4 Fogel EL, Eversman D, Jamidar P. et al. Sphincter of Oddi dysfunction: pancreaticobiliary sphincterotomy with pancreatic stent placement has a lower rate of pancreatitis than biliary sphincterotomy alone. Endoscopy 2002; 34: 280-285
• 5 Dumonceau JM, Andriulli A, Elmunzer BJ. et al. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy 2014; 46: 799-815
• 6 Levenick JM, Gordon SR, Fadden LL. et al. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology 2016; 150: 911-917
• 7 Freeman ML, Kozarek RA. Take 2 indomethacin (suppositories) and call me in the morning? the role of nonsteroidal anti-inflammatory drugs in protection against post-endoscopic retrograde cholangiopancreatography pancreatitis. Gastroenterology 2016; 150: 805-808
• 8 Luo H, Zhao L, Leung J. et al. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet 2016; 387: 2293-2301
• 9 Mazaki T, Mado K, Masuda H. et al. Prophylactic pancreatic stent placement and post-ERCP pancreatitis: an updated meta-analysis. J Gastroenterol 2014; 49: 343-355
• 10 Sofuni A, Maguchi H, Mukai T. et al. Endoscopic pancreatic duct stents reduce the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients. Clin Gastroenterol Hepatol 2011; 9: 851-858 ; quiz e110
• 11 Gasslander T, Holmberg B, Permert J. Pancreas 2000 – a new concept for education and development in pancreatology. Pancreatology 2005; 5: 545-546
• 12 Herreros de Tejada A, Calleja JL, Diaz G. et al. Double-guidewire technique for difficult bile duct cannulation: a multicenter randomized, controlled trial. Gastrointest Endosc 2009; 70: 700-709
• 13 Madacsy L, Kurucsai G, Fejes R. et al. Prophylactic pancreas stenting followed by needle-knife fistulotomy in patients with sphincter of Oddi dysfunction and difficult cannulation: new method to prevent post-ERCP pancreatitis. Dig Endosc 2009; 21: 8-13
• 14 Banks PA, Bollen TL, Dervenis C. et al. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut 2013; 62: 102-111
• 15 Harrell FE. Regression Modeling Strategies. New York, NY: Springer; 2001
• 16 Kay R. Statistical principles for clinical trials. J Int Med Res 1998; 26: 57-65
• 17 Bender R. Calculating confidence intervals for the number needed to treat. Control Clin Trials 2001; 22: 102-110
• 18 Freeman ML. Preventing Post-ERCP pancreatitis: Update 2016. Curr Treat Options Gastroenterol 2016; 14: 340-347
• 19 Kochar B, Akshintala VS, Afghani E. et al. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc 2015; 81: 143-149 e149
• 20 Ding X, Zhang F, Wang Y. Risk factors for post-ERCP pancreatitis: A systematic review and meta-analysis. Surgeon 2015; 13: 218-229
• 21 Freeman ML, DiSario JA, Nelson DB. et al. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc 2001; 54: 425-434
• 22 Phillip V, Schwab M, Haf D. et al. Identification of risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis in a high volume center. PLoS One 2017; 12: e0177874
• 23 Nakai Y, Isayama H, Sasahira N. et al. Risk factors for post-ERCP pancreatitis in wire-guided cannulation for therapeutic biliary ERCP. Gastrointest Endosc 2015; 81: 119-126
• 24 Buxbaum J, Leonor P, Tung J. et al. Randomized trial of endoscopist-controlled vs. assistant-controlled wire-guided cannulation of the bile duct. Am J Gastroenterol 2016; 111: 1841-1847
• 25 Srinivasan I, Freeman ML. Editorial: Guidewire Trauma: A key component of post-ercp pancreatitis that is best controlled by the endoscopist. Am J Gastroenterol 2016; 111: 1848-1850
• 26 Testoni PA. Why the incidence of post-ERCP pancreatitis varies considerably? Factors affecting the diagnosis and the incidence of this complication. JOP 2002; 3: 195-201
• 27 Matsubayashi H, Fukutomi A, Kanemoto H. et al. Risk of pancreatitis after endoscopic retrograde cholangiopancreatography and endoscopic biliary drainage. HPB 2009; 11: 222-228
• 28 Parekh PJ, Majithia R, Sikka SK. et al. The “scope” of post-ERCP pancreatitis. Mayo Clin Proc 2017; 92: 434-448
• 29 Shi QQ, Ning XY, Zhan LL. et al. Placement of prophylactic pancreatic stents to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: a meta-analysis. World J Gastroenterol 2014; 20: 7040-7048
• 30 Lee TH, Moon JH, Choi HJ. et al. Prophylactic temporary 3F pancreatic duct stent to prevent post-ERCP pancreatitis in patients with a difficult biliary cannulation: a multicenter, prospective, randomized study. Gastrointest Endosc 2012; 76: 578-585
• 31 Dumonceau JM, Rigaux J, Kahaleh M. et al. Prophylaxis of post-ERCP pancreatitis: a practice survey. Gastrointest Endosc 2010; 71: 934-939
• 32 Freeman ML. Use of Prophylactic Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis. Gastroenterol Hepatol (NY) 2015; 11: 420-422
• 33 Pahk A, Rigaux J, Poreddy V. et al. Prophylactic pancreatic stents: does size matter? A comparison of 4-Fr and 5-Fr stents in reference to post-ERCP pancreatitis and migration rate. Dig Dis Sci 2011; 56: 3058-3064
• 34 Rashdan A, Fogel EL, McHenry L. et al. Improved stent characteristics for prophylaxis of post-ERCP pancreatitis. Clin Gastroenterol Hepatol 2004; 2: 322-329
• 35 Afghani E, Akshintala VS, Khashab MA. et al. 5-Fr vs. 3-Fr pancreatic stents for the prevention of post-ERCP pancreatitis in high-risk patients: a systematic review and network meta-analysis. Endoscopy 2014; 46: 573-580
• 36 Olsson G, Lubbe J, Arnelo U. et al. The impact of prophylactic pancreatic stenting on post-ERCP pancreatitis: A nationwide, register-based study. United European Gastroenterol J 2017; 5: 111-118
• 37 Moffatt DC, Pradermchai K, Avula H. et al. Moderate and severe postendoscopic retrograde cholangiopancreatography pancreatitis despite prophylactic pancreatic stent placement: the effect of early prophylactic pancreatic stent dislodgement. Can J Gastroenterol 2011; 25: 215-219
• 38 Akbar A, Abu Dayyeh BK, Baron TH. et al. Rectal nonsteroidal anti-inflammatory drugs are superior to pancreatic duct stents in preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a network meta-analysis. Clin Gastroenterol Hepatol 2013; 11: 778-783