Abstract

This is one of a series of position statements discussing the use of GI endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy prepared this text. This document is an update of a previous ASGE publication.1Mallery J.S. Baron T.H. Dominitz J.A. et al.Complications of ERCP.Gastrointest Endosc. 2003; 57: 633-638Abstract Full Text Full Text PDF PubMed Scopus (161) Google Scholar In preparing this document, a search of the medical literature was performed using PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When limited or no data exist from well-designed prospective trials, emphasis is given to results from large series and reports from recognized experts. Position statements are based on a critical review of the available data and expert consensus at the time that the document was drafted. Further controlled clinical studies may be needed to clarify aspects of this document, which may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. This document is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This position statement is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient's condition and available courses of action. Therefore, clinical considerations may lead an endoscopist to take a course of action that varies from this position statement. Since its introduction in 1968, ERCP has become a commonly performed endoscopic procedure.2McCune W.S. Shorb P.E. Moscovitz H. Endoscopic cannulation of the ampulla of Vater: a preliminary report.Ann Surg. 1968; 167: 752-756Crossref PubMed Scopus (488) Google Scholar The diagnostic and therapeutic utility of ERCP has been well demonstrated for a variety of disorders, including the management of choledocholithiasis, the diagnosis and management of biliary and pancreatic neoplasms, and the postoperative management of biliary perioperative complications.3Maple J.T. Ben-Menachem T. Anderson M.A. et al.The role of endoscopy in the evaluation of suspected choledocholithiasis.Gastrointest Endosc. 2010; 71: 1-9Abstract Full Text Full Text PDF PubMed Scopus (350) Google Scholar, 4Baron T.H. Mallery J.S. Hirota W.K. et al.The role of endoscopy in the evaluation and treatment of patients with pancreaticobiliary malignancy.Gastrointest Endosc. 2003; 58: 643-649Abstract Full Text Full Text PDF PubMed Scopus (62) Google Scholar, 5Costamagna G. Shah S.K. Tringali A. Current management of postoperative complications and benign biliary strictures.Gastrointest Endosc Clin N Am. 2003; 13 (ix): 635-648Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar The evolution of the role of ERCP has occurred simultaneously with that of other diagnostic and therapeutic modalities, most notably magnetic resonance imaging/MRCP, laparoscopic cholecystectomy (with or without intraoperative cholangiography), and EUS. For endoscopists to accurately assess the clinical appropriateness of ERCP, it is important to have a thorough understanding of the potential complications of this procedure. Numerous studies have helped determine the expected rates of complications, potential contributing factors for these adverse events, and possible methods for improving the safety of ERCP. Recognition and understanding of potential complications of ERCP are vital in the acquisition of appropriate informed consent.6Zuckerman M.J. Shen B. Harrison 3rd, M.E. et al.Informed consent for GI endoscopy.Gastrointest Endosc. 2007; 66: 213-218Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar Reported complication rates vary widely in the published literature because of differences in study design, patient population, and definitions of complications. The diagnosis and management of all complications of ERCP are beyond the scope of this document; however, general principles are discussed. Pancreatitis is the most common serious ERCP complication.7Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2134) Google Scholar, 8Masci E. Toti G. Mariani A. et al.Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.Am J Gastroenterol. 2001; 96: 417-423Crossref PubMed Google Scholar, 9Freeman M.L. DiSario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis: a prospective, multicenter study.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (964) Google Scholar, 10Loperfido S. Angelini G. Benedetti G. et al.Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.Gastrointest Endosc. 1998; 48: 1-10Abstract Full Text Full Text PDF PubMed Scopus (1019) Google Scholar, 11Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (468) Google Scholar, 12Christensen M. Matzen P. Schulze S. et al.Complications of ERCP: a prospective study.Gastrointest Endosc. 2004; 60: 721-731Abstract Full Text Full Text PDF PubMed Scopus (342) Google Scholar, 13Rabenstein T. Schneider H.T. Bulling D. et al.Analysis of the risk factors associated with endoscopic sphincterotomy techniques: preliminary results of a prospective study, with emphasis on the reduced risk of acute pancreatitis with low-dose anticoagulation treatment.Endoscopy. 2000; 32: 10-19Crossref PubMed Scopus (117) Google Scholar, 14Williams E.J. Taylor S. Fairclough P. et al.Risk factors for complication following ERCP; results of a large-scale, prospective multicenter study.Endoscopy. 2007; 39: 793-801Crossref PubMed Scopus (291) Google Scholar, 15Colton J.B. Curran C.C. Quality indicators, including complications, of ERCP in a community setting: a prospective study.Gastrointest Endosc. 2009; 70: 457-467Abstract Full Text Full Text PDF PubMed Scopus (104) Google Scholar Although transient increase in serum pancreatic enzymes may occur in as many as 75% of patients,16Freeman M.L. Guda N.M. Prevention of post-ERCP pancreatitis: a comprehensive review.Gastrointest Endosc. 2004; 59: 845-864Abstract Full Text Full Text PDF PubMed Scopus (388) Google Scholar such an increase does not necessarily constitute pancreatitis. A widely used consensus definition for post-ERCP pancreatitis (PEP) is (1) new or worsened abdominal pain, (2) new or prolongation of hospitalization for at least 2 days, and (3) serum amylase 3 times or more the upper limit of normal, measured more than 24 hours after the procedure.17Cotton P.B. Lehman G. Vennes J. et al.Endoscopic sphincterotomy complications and their management: an attempt at consensus.Gastrointest Endosc. 1991; 37: 383-393Abstract Full Text PDF PubMed Scopus (2357) Google Scholar By using this or similar definitions, the incidence of PEP in a meta-analysis of 21 prospective studies was approximately 3.5%18Andriulli A. Loperfido S. Napolitano G. et al.Incidence rates of post-ERCP complications: a systematic survey of prospective studies.Am J Gastroenterol. 2007; 102: 1781-1788Crossref PubMed Scopus (683) Google Scholar but ranges widely (1.6%-15.7%) depending on patient selection.19Cotton P.B. Garrow D.A. Gallagher J. et al.Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years.Gastrointest Endosc. 2009; 70: 80-88Abstract Full Text Full Text PDF PubMed Scopus (455) Google Scholar, 20Barthet M. Lesavre N. Desjeux A. et al.Complications of endoscopic sphincterotomy: results from a single tertiary referral center.Endoscopy. 2002; 34: 991-997Crossref PubMed Scopus (111) Google Scholar The rates of PEP in pediatric patients approach those seen in adults.21Cheng C.L. Fogel E.L. Sherman S. et al.Diagnostic and therapeutic endoscopic retrograde cholangiopancreatography in children: a large series report.J Pediatr Gastroenterol Nutr. 2005; 41: 445-453Crossref PubMed Scopus (104) Google Scholar Numerous factors have been found to correlate with the development of PEP. Some of these are patient specific (eg, age, sex, history of PEP), whereas others are related to the procedure itself (eg, pancreatic sphincterotomy, precut sphincterotomy) or endoscopist experience. Risk factors for PEP that have been studied in large, prospective multivariate analyses are summarized in Table 1.22Freeman M.L. Adverse outcomes of ERCP.Gastrointest Endosc. 2002; 56: S273-S282Abstract Full Text Full Text PDF PubMed Google Scholar Risk factors can be synergistic. For example, Freeman et al9Freeman M.L. DiSario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis: a prospective, multicenter study.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (964) Google Scholar demonstrated that the risk of pancreatitis in a female with a normal bilirubin level and suspected sphincter of Oddi dysfunction (SOD) is 18% compared with 1.1% for a typical low-risk patient. Risk of PEP associated with the use of a precut or access papillotomy is controversial. Factors such as endoscopist experience and timing of precut may affect the risk, although the literature is mixed.7Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2134) Google Scholar, 8Masci E. Toti G. Mariani A. et al.Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.Am J Gastroenterol. 2001; 96: 417-423Crossref PubMed Google Scholar, 10Loperfido S. Angelini G. Benedetti G. et al.Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.Gastrointest Endosc. 1998; 48: 1-10Abstract Full Text Full Text PDF PubMed Scopus (1019) Google Scholar, 23Masci E. Mariani A. Curioni S. Testoni P.A. Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis.Endoscopy. 2003; 35: 830-834Crossref PubMed Scopus (325) Google Scholar, 24Huibregtse K. Katon R.M. Tytgat G.N. Precut papillotomy via fine-needle knife papillotome: a safe and effective technique.Gastrointest Endosc. 1986; 32: 403-405Abstract Full Text PDF PubMed Scopus (166) Google Scholar, 25Binmoeller K.F. Seifert H. Gerke H. et al.Papillary roof incision using the Erlangen-type pre-cut papillotome to achieve selective bile duct cannulation.Gastrointest Endosc. 1996; 44: 689-695Abstract Full Text Full Text PDF PubMed Scopus (119) Google Scholar, 26Vandervoort J. Carr-Locke D.L. Needle-knife access papillotomy: an unfairly maligned technique?.Endoscopy. 1996; 28: 365-366Crossref PubMed Scopus (60) Google Scholar, 27Bailey A.A. Bourke M.J. Kaffes A.J. et al.Needle-knife sphincterotomy: factors predicting its use and the relationship with post-ERCP pancreatitis (with video).Gastrointest Endosc. 2010; 71: 266-271Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar, 28Tang S.J. Haber G.B. Kortan P. et al.Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial.Endoscopy. 2005; 37: 58-65Crossref PubMed Scopus (96) Google Scholar, 29Cennamo V. Fuccio L. Repici A. et al.Timing of precut procedure does not influence success rate and complications of ERCP procedure: a prospective randomized comparative study.Gastrointest Endosc. 2009; 69: 473-479Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar ERCP in the setting of suspected SOD is associated with increased risk of pancreatitis (as high as 20%-25%), irrespective of whether manometry is performed.9Freeman M.L. DiSario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis: a prospective, multicenter study.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (964) Google Scholar When performed with aspiration-type catheters, manometry was not associated with an incremental increased risk of pancreatitis in multivariate analysis.9Freeman M.L. DiSario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis: a prospective, multicenter study.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (964) Google Scholar, 30Sherman S. Troiano F.P. Hawes R.H. et al.Sphincter of Oddi manometry: decreased risk of clinical pancreatitis with use of a modified aspirating catheter.Gastrointest Endosc. 1990; 36: 462-466Abstract Full Text PDF PubMed Scopus (158) Google Scholar Endoscopic papillary balloon dilation has been proposed as an alternative to endoscopic biliary sphincterotomy; however, 2 meta-analyses have shown a statistically significant increased risk of PEP with endoscopic papillary balloon dilation compared with standard sphincterotomy.31Baron T.H. Harewood G.C. Endoscopic balloon dilation of the biliary sphincter compared to endoscopic biliary sphincterotomy for removal of common bile duct stones during ERCP: a metaanalysis of randomized, controlled trials.Am J Gastroenterol. 2004; 99: 1455-1460Crossref PubMed Scopus (273) Google Scholar, 32Weinberg B.M. Shindy W. Lo S. Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones.Cochrane Database Syst Rev. 2006; (CD004890)PubMed Google ScholarTABLE 1Risk factors for post-ERCP pancreatitis in multivariate analysesModified from Freeman.22Freeman M.L. Adverse outcomes of ERCP.Gastrointest Endosc. 2002; 56: S273-S282Abstract Full Text Full Text PDF PubMed Google ScholarBalloon dilation of biliary sphincterHistory of post-ERCP pancreatitisNormal bilirubinPancreatic duct injectionPancreatic sphincterotomyPrecut sphincterotomySuspected sphincter of Oddi dysfunctionYoung age Open table in a new tab Recognition and understanding of risk factors for PEP have allowed endoscopists to provide a more accurate estimate of an individual's risk of PEP and to direct preventive measures in appropriate clinical situations. Appropriate patient selection is instrumental in reducing PEP. Other imaging modalities should first be considered for the diagnosis of common bile duct stones and pancreaticobiliary malignancy. Many of the variables identified in multivariate analyses (Table 1) can be assessed pre-procedure and should be accounted for when considering ERCP. In general, alternatives to ERCP should be considered when multiple risk factors are present and the likelihood of therapeutic intervention is low. MRCP and EUS both have sensitivity similar to that of ERCP for the detection of many pancreaticobiliary disorders without the associated risk of pancreatitis.3Maple J.T. Ben-Menachem T. Anderson M.A. et al.The role of endoscopy in the evaluation of suspected choledocholithiasis.Gastrointest Endosc. 2010; 71: 1-9Abstract Full Text Full Text PDF PubMed Scopus (350) Google Scholar, 33Romagnuolo J. Bardou M. Rahme E. et al.Magnetic resonance cholangiopancreatography: a meta-analysis of test performance in suspected biliary disease.Ann Intern Med. 2003; 139: 547-557Crossref PubMed Scopus (321) Google Scholar, 34Dave M. Elmunzer B.J. Dwamena B.A. et al.Primary sclerosing cholangitis: meta-analysis of diagnostic performance of MR cholangiopancreatography.Radiology. 2010; 256: 387-396Crossref PubMed Scopus (174) Google Scholar, 35Kinney T. Evidence-based imaging of pancreatic malignancies.Surg Clin North Am. 2010; 90: 235-249Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar ERCP should be reserved for those patients with a reasonable likelihood of requiring therapeutic intervention, based on either clinical criteria (eg, cholangitis) or abnormalities identified by other imaging modalities. Several agents for the pharmacologic prophylaxis of PEP have been proposed, each directed toward the interruption or amelioration of some aspect of the inflammatory cascade that accompanies and potentiates acute pancreatitis. Meta-analyses have shown a statistically significant reduction of PEP with indomethacin or diclofenac given rectally just before ERCP or on arrival at the recovery room.36Elmunzer B.J. Waljee A.K. Elta G.H. et al.A meta-analysis of rectal NSAIDs in the prevention of post-ERCP pancreatitis.Gut. 2008; 57: 1262-1267Crossref PubMed Scopus (199) Google Scholar, 37Zheng M.H. Xia H.H. Chen Y.P. Rectal administration of NSAIDs in the prevention of post-ERCP pancreatitis: a complementary meta-analysis.Gut. 2008; 57: 1632-1633PubMed Google Scholar, 38Dai H.F. Wang X.W. Zhao K. Role of nonsteroidal anti-inflammatory drugs in the prevention of post-ERCP pancreatitis: a meta-analysis.Hepatobiliary Pancreat Dis Int. 2009; 8: 11-16PubMed Google Scholar Many studies were limited to high-risk patients. However, other studies of oral nonsteroidal anti-inflammatory drugs have shown no benefit.39Cheon Y.K. Cho K.B. Watkins J.L. 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: 1126-1132Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar Nitroglycerin was shown to reduce the incidence of PEP in 2 meta-analyses, but methodologic limitations and the side-effect profile of nitroglycerin hinder it from being recommended in the prevention of PEP.40Bang U.C. Nojgaard C. Andersen P.K. et al.Meta-analysis: nitroglycerin for prevention of post-ERCP pancreatitis.Aliment Pharmacol Ther. 2009; 29: 1078-1085Crossref PubMed Scopus (33) Google Scholar, 41Shao L.M. Chen Q.Y. Chen M.Y. et al.Nitroglycerin in the prevention of post-ERCP pancreatitis: a meta-analysis.Dig Dis Sci. 2010; 55: 1-7Crossref PubMed Scopus (43) Google Scholar, 42Dumonceau J.M. Andriulli A. Deviere J. et al.European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis.Endoscopy. 2010; 42: 503-515Crossref PubMed Scopus (233) Google Scholar Other meta-analyses have found no benefit from somatostatin, octreotide, or low osmolality contrast for the prevention of PEP.42Dumonceau J.M. Andriulli A. Deviere J. et al.European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis.Endoscopy. 2010; 42: 503-515Crossref PubMed Scopus (233) Google Scholar, 43George S. Kulkarni A.A. Stevens G. et al.Role of osmolality of contrast media in the development of post-ERCP pancreatitis: a metanalysis.Dig Dis Sci. 2004; 49: 503-508Crossref PubMed Scopus (43) Google Scholar Finally, additional studies have shown that glucocorticoids and gabexate are ineffective in the prevention of PEP.44Zheng M. Bai J. Yuan B. et al.Meta-analysis of prophylactic corticosteroid use in post-ERCP pancreatitis.BMC Gastroenterol. 2008; 8: 6Crossref PubMed Scopus (48) Google Scholar, 45Zheng M. Chen Y. Yang X. et al.Gabexate in the prophylaxis of post-ERCP pancreatitis: a meta-analysis of randomized controlled trials.BMC Gastroenterol. 2007; 7: 6Crossref PubMed Scopus (37) Google Scholar, 46Bai Y. Gao J. Shi X. et al.Prophylactic corticosteroids do not prevent post-ERCP pancreatitis: a meta-analysis of randomized controlled trials.Pancreatology. 2008; 8: 504-509Abstract Full Text PDF PubMed Scopus (31) Google Scholar Multiple prospective studies have shown the benefits of temporary pancreatic duct (PD) stents in lowering the risk and severity of PEP in high-risk populations, such as those undergoing SOD manometry, ampullectomy, pancreatic sphincterotomy, precut sphincterotomy, pancreatic brush cytology, difficult biliary cannulation, and manipulation of the PD with wires.47Freeman M.L. Pancreatic stents for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis.Clin Gastroenterol Hepatol. 2007; 5: 1354-1365Abstract Full Text Full Text PDF PubMed Scopus (156) Google Scholar, 48Ito K. Fujita N. Noda Y. et al.Can pancreatic duct stenting prevent post-ERCP pancreatitis in patients who undergo pancreatic duct guidewire placement for achieving selective biliary cannulation? A prospective randomized controlled trial.J Gastroenterol. 2010; 45: 1183-1191Crossref PubMed Scopus (110) Google Scholar In a systematic review involving 680 patients in 8 studies, pancreatitis was significantly reduced with PD stents from 19% in controls to 6%. The number needed to treat to avoid a single episode of PEP with PD stent placement was 8.49Mazaki T. Masuda H. Takayama T. Prophylactic pancreatic stent placement and post-ERCP pancreatitis: a systematic review and meta-analysis.Endoscopy. 2010; 42: 842-853Crossref PubMed Scopus (133) Google Scholar A cost-effectiveness analysis suggested that PD stent placement in high-risk patients may be cost-effective for the prevention of PEP.50Das A. Singh P. Sivak Jr, M.V. et al.Pancreatic-stent placement for prevention of post-ERCP pancreatitis: a cost-effectiveness analysis.Gastrointest Endosc. 2007; 65: 960-968Abstract Full Text Full Text PDF PubMed Scopus (101) Google Scholar The use of wire-guided cannulation before contrast injection has been shown in meta-analyses to result in greater success of biliary cannulation and lower risk of PEP by avoiding the injection of contrast into the pancreas.51Cennamo V. Fuccio L. Zagari R.M. et al.Can a wire-guided cannulation technique increase bile duct cannulation rate and prevent post-ERCP pancreatitis? A meta-analysis of randomized controlled trials.Am J Gastroenterol. 2009; 104: 2343-2350Crossref PubMed Scopus (115) Google Scholar, 52Shao L.M. Chen Q.Y. Chen M.Y. et al.Can wire-guided cannulation reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis? A meta-analysis of randomized controlled trials.J Gastroenterol Hepatol. 2009; 24: 1710-1715Crossref PubMed Scopus (32) Google Scholar Data are mixed as to whether inadvertent wire-guided cannulation of the PD is an independent risk factor for PEP.53Wang P. Li Z.S. Liu F. et al.Risk factors for ERCP-related complications: a prospective multicenter study.Am J Gastroenterol. 2009; 104: 31-40Crossref PubMed Scopus (315) Google Scholar, 54Artifon E.L. Sakai P. Cunha J.E. et al.Guidewire cannulation reduces risk of post-ERCP pancreatitis and facilitates bile duct cannulation.Am J Gastroenterol. 2007; 102: 2147-2153Crossref PubMed Scopus (138) Google Scholar A meta-analysis of 4 studies comparing pure-cut current versus blended current in patients undergoing endoscopic biliary sphincterotomy demonstrated no statistically significant difference in the rate of PEP.55Verma D. Kapadia A. Adler D.G. Pure versus mixed electrosurgical current for endoscopic biliary sphincterotomy: a meta-analysis of adverse outcomes.Gastrointest Endosc. 2007; 66: 283-290Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar Most ERCP-associated bleeding is intraluminal, although intraductal bleeding can occur and hematomas (hepatic, splenic, and intra-abdominal) have been reported.56Costa Macedo T. Maldonado R. Valente A. et al.Hemobilia in hereditary hemorrhagic telangiectasia: an unusual complication of endoscopic retrograde cholangiopancreatography.Endoscopy. 2003; 35: 531-533Crossref PubMed Scopus (17) Google Scholar, 57Kingsley D.D. Schermer C.R. Jamal M.M. Rare complications of endoscopic retrograde cholangiopancreatography: two case reports.JSLS. 2001; 5: 171-173PubMed Google Scholar, 58McArthur K.S. Mills P.R. Subcapsular hepatic hematoma after ERCP.Gastrointest Endosc. 2008; 67: 379-380Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar Hemorrhage is primarily a complication related to sphincterotomy rather than diagnostic ERCP. In a meta-analysis of 21 prospective trials, the rate of hemorrhage as a complication of ERCP was 1.3% (95% CI, 1.2%-1.5%) with 70% of the bleeding episodes classified as mild.18Andriulli A. Loperfido S. Napolitano G. et al.Incidence rates of post-ERCP complications: a systematic survey of prospective studies.Am J Gastroenterol. 2007; 102: 1781-1788Crossref PubMed Scopus (683) Google Scholar Hemorrhagic complications may be immediate or delayed, with recognition occurring up to 2 weeks after the procedure. The risk of severe hemorrhage (ie, requiring ≥5 units of blood, surgery, or angiography) is estimated to occur in fewer than 1 per 1000 sphincterotomies.59Freeman M.L. Adverse outcomes of endoscopic retrograde cholangiopancreatography: avoidance and management.Gastrointest Endosc Clin N Am. 2003; 13 (xi): 775-798Abstract Full Text Full Text PDF PubMed Scopus (58) Google Scholar Although sphincterotomy alone is a risk factor for hemorrhage, other factors identified in multivariate analysis include coagulopathy, the use of anticoagulants within 72 hours of sphincterotomy, the presence of acute cholangitis or papillary stenosis, the use of precut sphincterotomy, and low case volume of the endoscopist (ie, 1 sphincterotomy per week or less).7Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2134) Google Scholar, 8Masci E. Toti G. Mariani A. et al.Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.Am J Gastroenterol. 2001; 96: 417-423Crossref PubMed Google Scholar, 10Loperfido S. Angelini G. Benedetti G. et al.Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.Gastrointest Endosc. 1998; 48: 1-10Abstract Full Text Full Text PDF PubMed Scopus (1019) Google Scholar Observed bleeding during the initial examination is also predictive of delayed bleeding.7Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2134) Google Scholar Neither the length of incision nor the preprocedure use of aspirin or other nonsteroidal anti-inflammatory drugs appear to be important predictors of bleeding.7Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2134) Google Scholar A large, multicenter study of 4561 patients undergoing ERCP found that the risk of post-ERCP hemorrhage was associated with hemodialysis, visible bleeding during the procedure, higher bilirubin, and the use of pure-cut current for sphincterotomy.14Williams E.J. Taylor S. Fairclough P. et al.Risk factors for complication following ERCP; results of a large-scale, prospective multicenter study.Endoscopy. 2007; 39: 793-801Crossref PubMed Scopus (291) Google Scholar Antiplatelet treatment, precut sphincterotomy, coagulopathy, and cholangitis were not associated with post-ERCP hemorrhage. The use of a microprocessor-controlled ERBE electrosurgical generator for sphincterotomy has been associated with a lower rate of endoscopically visible bleeding, but not clinically evident bleeding compared with conventional electrocautery.60Perini R.F. Sadurski R. Cotton P.B. et al.Post-sphincterotomy bleeding after the introduction of microprocessor-controlled electrosurgery: does the new technology make the difference?.Gastrointest Endosc. 2005; 61: 53-57Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar More detailed data on the safety of various types of current are needed. Treatment of bleeding includes injection therapy with epinephrine, with or without thermal therapy, and endoscopic clips.61Ferreira L.E. Baron T.H. Post-sphincterotomy bleeding: who, what, when, and how.Am J Gastroenterol. 2007; 102: 2850-2858Crossref PubMed Scopus (94) Google Scholar ERCP with sphincterotomy is considered a higher risk procedure for bleeding, and antithrombotic therapy should be adjusted according to published guidelines.62Anderson M.A. Ben-Menachem T. Gan S.I. et al.Management of antithrombotic agents for endoscopic procedures.Gastrointest Endosc. 2009; 70: 1060-1070Abstract Full Text Full Text PDF PubMed Scopus (390) Google Scholar Perforation rates with ERCP range from 0.1% to 0.6%.7Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2134) Google Scholar, 8Masci E. Toti G. Mariani A. et al.Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.Am J Gastroenterol. 2001; 96: 417-423Crossref PubMed Google Scholar, 10Loperfido S. Angelini G. Benedetti G. et al.Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.Gastrointest Endosc. 1998; 48: 1-10Abstract Full Text Full Text PDF PubMed Scopus (1019) Google Scholar, 15Colton J.B. Curran C.C. Quality indicators, including complications, of ERCP in a community setting: a prospective study.Gastrointest Endosc. 2009; 70: 457-467Abstract Full Text Full Text PDF PubMed Scopus (104) Google Scholar, 63Howard T.J. Tan T. Lehman G.A. et al.Classification and management of perforations complicating endoscopic sphincterotomy.Surgery. 1999; 126 (discussion 64-5): 658-663Abstract Full Text Full Text PDF PubMed Scopus (172) Google Scholar Three distinct types of perforation have been described: guidewire-induced perforation, periampullary perforation during sphincterotomy, and luminal perforation at a site remote from the papilla.63Howard T.J. Tan T. Lehman G.A. et al.Classification and management of perforations complicating endoscopic sphincterotomy.Surgery. 1999; 126 (discussion 64-5): 658-663Abstract Full Text Full Text PDF PubMed Scopus (172) Google Scholar Risk factors for perforation determined in a large retrospective study included the performance of a sphincterotomy, Billroth II anatomy, the