Background and Aims: Although endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure used to treat conditions affecting the biliopancreatic system, it can lead to several complications. Post-ERCP pancreatitis (PEP) is the most frequent one, with an incidence ranging from 3 to 14%. Our aim was to assess the potential risk factors associated with PEP occurrence in patients undergoing ERCP with indomethacin prophylaxis. Methods: Prospective, single-center, real-world observational study (January to December 2015) with inclusion of patients submitted to ERCP, where relevant patient-related and procedure-related data had been collected. Patients had to have been admitted for a minimum of 24 h in order to establish the presence of early complications. All patients were submitted to PEP prophylaxis with 1 or 2 methods: rectal indomethacin and pancreatic duct (PD) stenting. Results: A total of 188 patients who had undergone ERCP were included (52.7% women; mean age 69.2 ± 16.0 years) and PEP was diagnosed in 13 (6.9%). PEP prophylaxis consisted of indomethacin in all cases (100%) and PD stenting in 7.4%. The pancreatitis was mild in 11 patients (84.6%) and severe in the other 2. One of them died (0.5%). None of the patient-related risk factors were associated with changes in PEP probability. Of all patients, 33.0% had 2 or more procedure-related risk factors. A higher number of synchronous procedure-related risk factors showed a statistically significant correlation with PEP occurrence, p = 0.040. Conclusions: The 6.9% PEP rate is considered acceptable since 33.0% patients had a medium-high risk for PEP due to challenging biliary cannulation. The total number of procedure-related risk factors seems to play a critical role in the development of PEP despite indomethacin prophylaxis.

Testoni PA, Mariani A, Aabakken L, et al: Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2016; 48: 657–683.
Andriulli A, Loperfido S, Napolitano G, et al: Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol 2007; 102: 1781–1788.
Kapral C, Mühlberger A, Wewalka F, et al: Quality assessment of endoscopic retrograde cholangiopancreatography: results of a running nationwide Austrian benchmarking project after 5 years of implementation. Eur J Gastroenterol Hepatol 2012; 24: 1447–1454.
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.
Masci E, Mariani A, Curioni S, et al: Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis. Endoscopy 2003; 35: 830–834.
Sutton VR, Hong MK, Thomas PR: Using the 4-h Post-ERCP amylase level to predict post-ERCP pancreatitis. JOP 2011; 12: 372–376.
Devière J, Le Moine O, Van Laethem JL, et al: Interleukin 10 reduces the incidence of pancreatitis after therapeutic endoscopic retrograde cholangiopancreatography. Gastroenterology 2001; 120: 498–505.
Arcidiacono R, Gambitta P, Rossi A, et al: The use of a long-acting somatostatin analogue (octreotide) for prophylaxis of acute pancreatitis after endoscopic sphincterotomy. Endoscopy 1994; 26: 715–718.
Andriulli A, Clemente R, Solmi L, et al: Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial. Gastrointest Endosc 2002; 56: 488–495.
Prat F, Amaris J, Ducot B, et al: Nifedipine for prevention of post-ERCP pancreatitis: a prospective, double-blind randomized study. Gastrointest Endosc 2002; 56: 202–208.
Budzyńska A, Marek T, Nowak A, et al: A prospective, randomized, placebo-controlled trial of prednisone and allopurinol in the prevention of ERCP-induced pancreatitis. Endoscopy 2001; 33: 766–772.
Rabenstein T, Fischer B, Wiessner V, et al: Low-molecular-weight heparin does not prevent acute post-ERCP pancreatitis. Gastrointest Endosc 2004; 59: 606–613.
Poon RT, Yeung C, Liu CL, et al: Intravenous bolus somatostatin after diagnostic cholangiopancreatography reduces the incidence of pancreatitis associated with therapeutic endoscopic retrograde cholangiopancreatography procedures: a randomised controlled trial. Gut 2003; 52: 1768–1773.
Andriulli A, Leandro G, Federici T, et al: Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis. Gastrointest Endosc 2007; 65: 624–632.
Sotoudehmanesh R, Khatibian M, Kolahdoozan S, et al: Indomethacin may reduce the incidence and severity of acute pancreatitis after ERCP. Am J Gastroenterol 2007; 102: 978–983.
Cheon YK, Cho KB, Watkins JL, et al: Efficacy of diclofenac in the prevention of post-ERCP pancreatitis in predominantly high-risk patients: a randomized double-blind prospective trial. Gastrointest Endosc 2007; 66: 1126–1132.
Elmunzer BJ, Waljee AK, Elta GH, et al: A meta-analysis of rectal NSAIDs in the prevention of post-ERCP pancreatitis. Gut 2008; 57: 1262–1267.
Elmunzer BJ, Scheiman JM, Lehman GA, et al: A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med 2012; 366: 1414–1422.
Tarnasky PR, Palesch YY Cunningham JT, et al: Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction. Gastroenterology 1998; 115: 1518–1524.
Mazaki T, Masuda H, Takayama T: Prophylactic pancreatic stent placement and post-ERCP pancreatitis: a systematic review and meta-analysis. Endoscopy 2010; 42: 842–853.
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.
Chandrasekhara V, Khashab MA, Muthusamy VR, et al: Adverse events associated with ERCP. Gastrointest Endosc 2017; 85: 32–47.
Cotton PB, Lehman G, Vennes J, et al: Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383–393.
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.
Ding X, Chen M, Huang S, et al: Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc 2012; 76: 1152–1159.
Sethi S, Sethi N, Wadhwa V, et al: A meta-analysis on the role of rectal diclofenac and indomethacin in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Pancreas 2014; 43: 190–197.
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.
Cotton PB, Garrow DA, Gallagher J, et al: Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc 2009; 70: 80–88.
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