Interpretation of European Society of Gastrointestinal Endoscopy (ESGE) guideline for ERCP-related adverse events (2019)_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Zhenwen ,  ZHU Liang

Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, P.R.China;

Corresponding author：

ZHU Liang, Email: 89493075@qq.com

Keywords：

Endoscopic retrograde cholangiopancreatography; Adverse events; Evidence-based medicine; Guideline; Interpretation

DOI：

10.7507/1672-2531.202002008

Video：

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Endoscopic retrograde cholangiopancreatography (ERCP) is currently the first-line minimally invasive diagnosis and treatment of biliary and pancreatic diseases. With the increasing popularity of ERCP, ERCP-related adverse events which include post-ERCP pancreatitis, cholecystitis, cholangitis, bleeding, perforation, etc., have received more and more attention. In response to the controversy and problems in the management of these adverse events, the European Society of Gastrointestinal Endoscopy published the guidelines for ERCP-related adverse events in December 2019. The paper interprets the key points in the guideline to provide references for clinical practice.

Citation： WANG Zhenwen, ZHU Liang. Interpretation of European Society of Gastrointestinal Endoscopy (ESGE) guideline for ERCP-related adverse events (2019). Chinese Journal of Evidence-Based Medicine, 2020, 20(6): 634-642. doi: 10.7507/1672-2531.202002008 Copy

1.	Dumonceau JM, Kapral C, Aabakken L, et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy, 2020, 52(2): 127-149.
2.	Shekelle PG, Woolf SH, Eccles M, et al. Developing clinical guidelines. West J Med, 1999, 170(6): 348-351.
3.	Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc, 1991, 37(3): 383-393.
4.	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(1): 102-111.
5.	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(8): 1781-1788.
6.	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(1): 143-149.
7.	Ding X, Zhang F, Wang Y. Risk factors for post-ERCP pancreatitis: a systematic review and meta-analysis. Surgeon, 2015, 13(4): 218-229.
8.	El Nakeeb A, El Hanafy E, Salah T, et al. Post-endoscopic retrograde cholangiopancreatography pancreatitis: Risk factors and predictors of severity. World J Gastrointest Endosc, 2016, 8(19): 709-715.
9.	Tang Z, Yang Y, Yang Z, et al. Early precut sphincterotomy does not increase the risk of adverse events for patients with difficult biliary access: a systematic review of randomized clinical trials with meta-analysis and trial sequential analysis. Medicine (Baltimore), 2018, 97(36): e12213.
10.	Sundaralingam P, Masson P, Bourke MJ. Early precut sphincterotomy does not increase risk during endoscopic retrograde cholangiopancreatography in patients with difficult biliary access: a meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol, 2015, 13(10): 1722-1729.
11.	Keswani RN, Qumseya BJ, O'Dwyer LC, et al. Association between endoscopist and center endoscopic retrograde cholangiopancreatography volume with procedure success and adverse outcomes: a systematic review and meta-analysis. Clin Gastroenterol Hepatol, 2017, 15(12): 1866-1875.
12.	Lee HJ, Cho CM, Heo J, et al. Impact of hospital volume and the experience of endoscopist on adverse events related to endoscopic retrograde cholangiopancreatography: a prospective observational study. Gut Liver, 2020, 14(2): 257-264.
13.	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(10035): 2293-2301.
14.	Fakoya AOJ, Omenyi P, Anthony P, et al. Stevens-johnson syndrome and toxic epidermal necrolysis; extensive review of reports of drug-induced etiologies, and possible therapeutic modalities. Open Access Maced J Med Sci, 2018, 6(4): 730-738.
15.	Vostinaru O. Adverse effects and drug interactions of the non-steroidal anti-inflammatory drugs. In Al-kaf AGA, ed. Nonsteroidal antiinflammatory drugs. Londen: InTech, 2017.
16.	Patai Á, Solymosi N, Patai AV. Does rectal indomethacin given for prevention of post-ERCP pancreatitis increase bleeding after biliary endoscopic sphincterotomy or cardiovascular mortality?: Post hoc analysis using prospective clinical trial data. Medicine (Baltimore), 2014, 93(26): e159.
17.	Park CH, Paik WH, Park ET, et al. Aggressive intravenous hydration with lactated Ringer's solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial. Endoscopy, 2018, 50(4): 378-385.
18.	Ding J, Jin X, Pan Y, et al. Glyceryl trinitrate for prevention of post-ERCP pancreatitis and improve the rate of cannulation: a meta-analysis of prospective, randomized, controlled trials. PLoS One, 2013, 8(10).
19.	Sotoudehmanesh R, Eloubeidi MA, Asgari AA, et al. A randomized trial of rectal indomethacin and sublingual nitrates to prevent post-ERCP pancreatitis. Am J Gastroenterol, 2014, 109(6): 903-909.
20.	Zhang ZF, Yang N, Zhao G, et al. Preventive effect of ulinastatin and gabexate mesylate on post-endoscopic retrograde cholangiopancreatography pancreatitis. Chin Med J (Engl), 2010, 123(18): 2600-2606.
21.	Park KT, Kang DH, Choi CW, et al. Is high-dose nafamostat mesilate effective for the prevention of post-ERCP pancreatitis, especially in high-risk patients? Pancreas, 2011, 40(8): 1215-1219.
22.	Xu LH, Qian JB, Gu LG, et al. Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by epinephrine sprayed on the papilla: Prevention of PEP by epinephrine spray. J Gastroenterol Hepatol, 2011, 26(7): 1139-1144.
23.	Matsushita M, Takakuwa H, Shimeno N, et al. Epinephrine sprayed on the papilla for prevention of post-ERCP pancreatitis. J Gastroenterol, 2009, 44(1): 71-75.
24.	Ito K, Fujita N, Kanno A, et al. Risk factors for post-ERCP pancreatitis in high risk patients who have undergone prophylactic pancreatic duct stenting: a multicenter retrospective study. Intern Med, 2011, 50(24): 2927-2932.
25.	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(7): 573-580.
26.	Minakari M, Sebghatollahi V, Sattari M, et al. Serum amylase and lipase levels for prediction of postendoscopic retrograde cholangiopancreatography pancreatitis. J Res Med Sci, 2018, 23: 54.
27.	Karjula H, Nordblad Schmidt P, Mäkelä J, et al. Prophylactic pancreatic duct stenting in severe acute necrotizing pancreatitis: a prospective randomized study. Endoscopy, 2019, 51(11): 1027-1034.
28.	Yokoe M, Hata J, Takada T, et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci, 2018, 25(1): 41-54.
29.	Thosani N, Zubarik RS, Kochar R, et al. Prospective evaluation of bacteremia rates and infectious complications among patients undergoing single-operator choledochoscopy during ERCP. Endoscopy, 2016, 48(5): 424-431.
30.	Othman MO, Guerrero R, Elhanafi S, et al. A prospective study of the risk of bacteremia in directed cholangioscopic examination of the common bile duct. Gastrointest Endosc, 2016, 83(1): 151-157.
31.	Thomas S, Patel RP, Oto A. Resolution of pneumobilia as a predictor of biliary stent occlusion. Clin Imaging, 2015, 39(4): 650-653.
32.	Reiner CS, Merkle EM, Bashir MR, et al. MRI assessment of biliary ductal obstruction: is there added value of T1-weighted gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid-enhanced MR cholangiography? AJR Am J Roentgenol, 2013, 201(1): W49-W56.
33.	Lin WC, Lin HH, Hung CY, et al. Clinical endoscopic management and outcome of post-endoscopic sphincterotomy bleeding. PLoS One, 2017, 12(5): e0177449.
34.	Oren A, Breumelhof R, Timmer R, et al. Abnormal clotting parameters before therapeutic ERCP: do they predict major bleeding? Eur J Gastroenterol Hepatol, 1999, 11(10): 1093-1097.
35.	Adike A, Al-Qaisi M, Baffy NJ, et al. International normalized ratio does not predict gastrointestinal bleeding after endoscopic retrograde cholangiopancreatography in patients with cirrhosis. Gastroenterology Res, 2017, 10(3): 177-181.
36.	Mangiavillano B, Montale A, Frazzoni L, et al. Endoscopic biliary self-expandable metallic stent in malignant biliary obstruction with or without sphincterotomy: systematic review and meta-analysis. Endosc Int Open, 2019, 7(1): E26-E35.
37.	Sawas T, Arwani N, Al Halabi S, et al. Sphincterotomy with endoscopic biliary drainage for severe acute cholangitis: a meta-analysis. Endosc Int Open, 2017, 5(2): E103-E109.
38.	Leung WK, But DY, Wong SY, et al. Prevention of post-sphincterotomy bleeding by proton pump inhibitor: A randomized controlled trial. J Dig Dis, 2018, 19(6): 369-376.
39.	Cirocchi R, Kelly MD, Griffiths EA, et al. A systematic review of the management and outcome of ERCP related duodenal perforations using a standardized classification system. Surgeon, 2017, 15(6): 379-387.
40.	Verlaan T, Voermans RP, van Berge Henegouwen MI, et al. Endoscopic closure of acute perforations of the GI tract: a systematic review of the literature. Gastrointest Endosc, 2015, 82(4): 618-628.
41.	Paspatis GA, Dumonceau JM, Barthet M, et al. Diagnosis and management of iatrogenic endoscopic perforations: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy, 2014, 46(8): 693-711.
42.	Park BK, Seo JH, Jeon HH, et al. A nationwide population-based study of common bile duct stone recurrence after endoscopic stone removal in Korea. J Gastroenterol, 2018, 53(5): 670-678.

1. Dumonceau JM, Kapral C, Aabakken L, et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy, 2020, 52(2): 127-149.
2. Shekelle PG, Woolf SH, Eccles M, et al. Developing clinical guidelines. West J Med, 1999, 170(6): 348-351.
3. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc, 1991, 37(3): 383-393.
4. 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(1): 102-111.
5. 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(8): 1781-1788.
6. 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(1): 143-149.
7. Ding X, Zhang F, Wang Y. Risk factors for post-ERCP pancreatitis: a systematic review and meta-analysis. Surgeon, 2015, 13(4): 218-229.
8. El Nakeeb A, El Hanafy E, Salah T, et al. Post-endoscopic retrograde cholangiopancreatography pancreatitis: Risk factors and predictors of severity. World J Gastrointest Endosc, 2016, 8(19): 709-715.
9. Tang Z, Yang Y, Yang Z, et al. Early precut sphincterotomy does not increase the risk of adverse events for patients with difficult biliary access: a systematic review of randomized clinical trials with meta-analysis and trial sequential analysis. Medicine (Baltimore), 2018, 97(36): e12213.
10. Sundaralingam P, Masson P, Bourke MJ. Early precut sphincterotomy does not increase risk during endoscopic retrograde cholangiopancreatography in patients with difficult biliary access: a meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol, 2015, 13(10): 1722-1729.
11. Keswani RN, Qumseya BJ, O'Dwyer LC, et al. Association between endoscopist and center endoscopic retrograde cholangiopancreatography volume with procedure success and adverse outcomes: a systematic review and meta-analysis. Clin Gastroenterol Hepatol, 2017, 15(12): 1866-1875.
12. Lee HJ, Cho CM, Heo J, et al. Impact of hospital volume and the experience of endoscopist on adverse events related to endoscopic retrograde cholangiopancreatography: a prospective observational study. Gut Liver, 2020, 14(2): 257-264.
13. 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(10035): 2293-2301.
14. Fakoya AOJ, Omenyi P, Anthony P, et al. Stevens-johnson syndrome and toxic epidermal necrolysis; extensive review of reports of drug-induced etiologies, and possible therapeutic modalities. Open Access Maced J Med Sci, 2018, 6(4): 730-738.
15. Vostinaru O. Adverse effects and drug interactions of the non-steroidal anti-inflammatory drugs. In Al-kaf AGA, ed. Nonsteroidal antiinflammatory drugs. Londen: InTech, 2017.
16. Patai Á, Solymosi N, Patai AV. Does rectal indomethacin given for prevention of post-ERCP pancreatitis increase bleeding after biliary endoscopic sphincterotomy or cardiovascular mortality?: Post hoc analysis using prospective clinical trial data. Medicine (Baltimore), 2014, 93(26): e159.
17. Park CH, Paik WH, Park ET, et al. Aggressive intravenous hydration with lactated Ringer's solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial. Endoscopy, 2018, 50(4): 378-385.
18. Ding J, Jin X, Pan Y, et al. Glyceryl trinitrate for prevention of post-ERCP pancreatitis and improve the rate of cannulation: a meta-analysis of prospective, randomized, controlled trials. PLoS One, 2013, 8(10).
19. Sotoudehmanesh R, Eloubeidi MA, Asgari AA, et al. A randomized trial of rectal indomethacin and sublingual nitrates to prevent post-ERCP pancreatitis. Am J Gastroenterol, 2014, 109(6): 903-909.
20. Zhang ZF, Yang N, Zhao G, et al. Preventive effect of ulinastatin and gabexate mesylate on post-endoscopic retrograde cholangiopancreatography pancreatitis. Chin Med J (Engl), 2010, 123(18): 2600-2606.
21. Park KT, Kang DH, Choi CW, et al. Is high-dose nafamostat mesilate effective for the prevention of post-ERCP pancreatitis, especially in high-risk patients? Pancreas, 2011, 40(8): 1215-1219.
22. Xu LH, Qian JB, Gu LG, et al. Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by epinephrine sprayed on the papilla: Prevention of PEP by epinephrine spray. J Gastroenterol Hepatol, 2011, 26(7): 1139-1144.
23. Matsushita M, Takakuwa H, Shimeno N, et al. Epinephrine sprayed on the papilla for prevention of post-ERCP pancreatitis. J Gastroenterol, 2009, 44(1): 71-75.
24. Ito K, Fujita N, Kanno A, et al. Risk factors for post-ERCP pancreatitis in high risk patients who have undergone prophylactic pancreatic duct stenting: a multicenter retrospective study. Intern Med, 2011, 50(24): 2927-2932.
25. 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(7): 573-580.
26. Minakari M, Sebghatollahi V, Sattari M, et al. Serum amylase and lipase levels for prediction of postendoscopic retrograde cholangiopancreatography pancreatitis. J Res Med Sci, 2018, 23: 54.
27. Karjula H, Nordblad Schmidt P, Mäkelä J, et al. Prophylactic pancreatic duct stenting in severe acute necrotizing pancreatitis: a prospective randomized study. Endoscopy, 2019, 51(11): 1027-1034.
28. Yokoe M, Hata J, Takada T, et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci, 2018, 25(1): 41-54.
29. Thosani N, Zubarik RS, Kochar R, et al. Prospective evaluation of bacteremia rates and infectious complications among patients undergoing single-operator choledochoscopy during ERCP. Endoscopy, 2016, 48(5): 424-431.
30. Othman MO, Guerrero R, Elhanafi S, et al. A prospective study of the risk of bacteremia in directed cholangioscopic examination of the common bile duct. Gastrointest Endosc, 2016, 83(1): 151-157.
31. Thomas S, Patel RP, Oto A. Resolution of pneumobilia as a predictor of biliary stent occlusion. Clin Imaging, 2015, 39(4): 650-653.
32. Reiner CS, Merkle EM, Bashir MR, et al. MRI assessment of biliary ductal obstruction: is there added value of T1-weighted gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid-enhanced MR cholangiography? AJR Am J Roentgenol, 2013, 201(1): W49-W56.
33. Lin WC, Lin HH, Hung CY, et al. Clinical endoscopic management and outcome of post-endoscopic sphincterotomy bleeding. PLoS One, 2017, 12(5): e0177449.
34. Oren A, Breumelhof R, Timmer R, et al. Abnormal clotting parameters before therapeutic ERCP: do they predict major bleeding? Eur J Gastroenterol Hepatol, 1999, 11(10): 1093-1097.
35. Adike A, Al-Qaisi M, Baffy NJ, et al. International normalized ratio does not predict gastrointestinal bleeding after endoscopic retrograde cholangiopancreatography in patients with cirrhosis. Gastroenterology Res, 2017, 10(3): 177-181.
36. Mangiavillano B, Montale A, Frazzoni L, et al. Endoscopic biliary self-expandable metallic stent in malignant biliary obstruction with or without sphincterotomy: systematic review and meta-analysis. Endosc Int Open, 2019, 7(1): E26-E35.
37. Sawas T, Arwani N, Al Halabi S, et al. Sphincterotomy with endoscopic biliary drainage for severe acute cholangitis: a meta-analysis. Endosc Int Open, 2017, 5(2): E103-E109.
38. Leung WK, But DY, Wong SY, et al. Prevention of post-sphincterotomy bleeding by proton pump inhibitor: A randomized controlled trial. J Dig Dis, 2018, 19(6): 369-376.
39. Cirocchi R, Kelly MD, Griffiths EA, et al. A systematic review of the management and outcome of ERCP related duodenal perforations using a standardized classification system. Surgeon, 2017, 15(6): 379-387.
40. Verlaan T, Voermans RP, van Berge Henegouwen MI, et al. Endoscopic closure of acute perforations of the GI tract: a systematic review of the literature. Gastrointest Endosc, 2015, 82(4): 618-628.
41. Paspatis GA, Dumonceau JM, Barthet M, et al. Diagnosis and management of iatrogenic endoscopic perforations: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy, 2014, 46(8): 693-711.
42. Park BK, Seo JH, Jeon HH, et al. A nationwide population-based study of common bile duct stone recurrence after endoscopic stone removal in Korea. J Gastroenterol, 2018, 53(5): 670-678.

Chinese Journal of Evidence-Based Medicine

Interpretation of European Society of Gastrointestinal Endoscopy (ESGE) guideline for ERCP-related adverse events (2019)

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