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Original Article

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Risk Factors for Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis in the Indomethacin Era – A Prospective Study

Perdigoto D.N.a,b · Gomes D.a,b · Almeida N.a,b · Mendes S.a · Alves A.R.a · Camacho E.a · Tomé L.a,b

Author affiliations

aGastroenterology Department, Coimbra Hospital and University Center, Coimbra, Portugal
bMedical School, Coimbra University, Coimbra, Portugal

Corresponding Author

Dr. David N. Perdigoto

Gastroenterology Department, Coimbra Hospital and University Center

Praceta Prof. Mota Pinto

PT–3000-075 Coimbra (Portugal)

E-Mail davidperdigoto@gmail.com

Keywords: Endoscopic retrograde cholangiopancreatographyPost-ERCP pancreatitisIndomethacinPancreatic duct stentERCP complications

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GE Port J Gastroenterol 2019;26:176–183
https://doi.org/10.1159/000492313

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Abstract

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.

© 2018 Sociedade Portuguesa de Gastrenterologia Published by S. Karger AG, Basel

Fatores de Risco para a Pancreatite pós-Colangiopancreatografia Retrógrada Endoscópica na Era da Indometacina – Um Estudo Prospetivo

Palavras Chave

CPRE · Pancreatite pós-CPRE · Indometacina · Prótese pancreática · Complicações de CPRE ·

Resumo

Introdução e objetivo: A colangiopancreatografia re­trógrada endoscópica (CPRE) é um método terapêutico crucial em doenças biliopancreáticas, mas pode levar a várias complicações. A pancreatite pós-CPRE (PPC) é a complicação mais frequente, podendo atingir uma incidência de 3 a 14%. O objetivo foi estudar os fatores de risco associados à PPC em doentes submetidos a CPRE com profilaxia por indometacina. Métodos: Estudo prospetivo e observacional com inclusão (janeiro-dezembro 2015) de doentes submetidos a CPRE num centro terciário, em condições de prática real. Foram registados os dados relevantes do doente e procedimento. Os doentes foram observados em internamento por, pelo menos, 24 horas para deteção de complicações. Todos os doentes incluídos foram submetidos a profilaxia de PPC, com recurso a um ou dois métodos: indometacina retal e prótese pancreática. Resultados: Estudados 188 doentes, 52.7% mulheres, com idade média de 69.2 ± 16.0 anos. Profilaxia de PPC envolveu indometacina em todos os casos (100%) e colocação de prótese pancreática em 7.4%. Registou-se PPC em 13 doentes (6.9%), sendo que 11 (84.6% de PPC) tiveram pancreatite ligeira. Os restantes dois apresentaram pancreatite grave e um deles faleceu (0.5%). Nenhum dos fatores de risco do doente se relacionou com maior probabilidade de PPC. Do total de doentes, em 33.0% estiveram presentes 2 ou mais fatores de risco associados ao procedimento. A presença simultânea de um número superior de fatores de risco associados ao procedimento relacionou-se significativamente com a ocorrência de PPC, p = 0.040. Conclusões: Considera-se aceitável a taxa de PPC de 6.9%, tendo em conta que 33.0% dos doentes apresentavam risco médio-alto para PPC devido a canulação biliar difícil. O número total de fatores de risco associados ao procedimento parece desempenhar um papel crucial no desenvolvimento de PPC, apesar da profilaxia com indometacina.



Related Articles:

References

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Masci E, Mariani A, Curioni S, et al: Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis. Endoscopy 2003; 35: 830–834.
  6. Sutton VR, Hong MK, Thomas PR: Using the 4-h Post-ERCP amylase level to predict post-ERCP pancreatitis. JOP 2011; 12: 372–376.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. Chandrasekhara V, Khashab MA, Muthusamy VR, et al: Adverse events associated with ERCP. Gastrointest Endosc 2017; 85: 32–47.
  23. Cotton PB, Lehman G, Vennes J, et al: Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383–393.
  24. 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.
  25. 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.
  26. 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.
  27. 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.
  28. 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.

Article / Publication Details

First-Page Preview
Abstract of Original Article

Received: January 24, 2018
Accepted: July 23, 2018
Published online: September 03, 2018
Issue release date: May - June

Number of Print Pages: 8
Number of Figures: 1
Number of Tables: 3

ISSN: 2341-4545 (Print)
eISSN: 2387-1954 (Online)

For additional information: https://www.karger.com/PJG

References

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Masci E, Mariani A, Curioni S, et al: Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis. Endoscopy 2003; 35: 830–834.
  6. Sutton VR, Hong MK, Thomas PR: Using the 4-h Post-ERCP amylase level to predict post-ERCP pancreatitis. JOP 2011; 12: 372–376.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. Chandrasekhara V, Khashab MA, Muthusamy VR, et al: Adverse events associated with ERCP. Gastrointest Endosc 2017; 85: 32–47.
  23. Cotton PB, Lehman G, Vennes J, et al: Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383–393.
  24. 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.
  25. 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.
  26. 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.
  27. 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.
  28. 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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