Advertisement

Surgical Endoscopy

, Volume 31, Issue 2, pp 602–610 | Cite as

Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial

  • Goran HauserEmail author
  • Ivana Blažević
  • Nermin Salkić
  • Goran Poropat
  • Vanja Giljača
  • Zlatko Bulić
  • Davor Štimac
Article

Abstract

Background and Aims

We aimed to compare the efficacy of prophylactic, parenterally administered ceftazidime and rectally applied diclofenac sodium for the prophylaxis of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP).

Methods

We prospectively enrolled patients who underwent ERCP. In a double-blind, randomized, controlled trial, patients received a suppository containing diclofenac sodium rectally (100 mg) and placebo intravenously (group A) or ceftazidime intravenously (1 g) and placebo rectally (group B) immediately before the procedure. The serum and urine amylase levels were recorded and the patients were clinically evaluated after ERCP.

Results

Of the 272 patients enrolled (group A: 129; group B: 143), 32 developed pancreatitis (group A: 11 [8.5 %]; group B: 21 [14.7 %]; P = 0.17; relative risk = 1.72; 95 % confidence interval [CI] = 0.86–3.43). The severity of the pancreatitis or complications did not significantly differ between the groups. A serum amylase level of ≥560 U/L and urine amylase level of ≥1150 U/L indicated a positive likelihood ratio for post-ERCP pancreatitis of ≥10. Moreover, the threshold visual analog scale score of ≤5 for abdominal pain after ERCP had excellent diagnostic potential for predicting the presence or absence of post-ERCP pancreatitis.

Conclusions

The PEP incidence did not differ between the ceftazidime and diclofenac sodium groups. In patients with nonsteroidal anti-inflammatory drug contraindications, antibiotics can be considered a safe alternative to diclofenac sodium for PEP prevention. Moreover, the visual analog scale for abdominal pain has excellent diagnostic value for predicting PEP.

Clinical trials.gov number

NCT 01784445.

Keywords

Anti-inflammatory agents Nonsteroidal ERCP Pancreatitis 

Notes

Acknowledgments

We would like to thank the endoscopy staff and nurses working for Department of Gastroenterology in University Hospital Rijeka since without their help it would be impossible to finish this study.

Funding

Grant support: University of Rijeka research Grant Number: 13.06.1.2.30.

Authors’ contributions

GH was involved in study concept and design, acquisition of data, critical revision of the manuscript for important intellectual content, analysis and interpretation of data, and drafting the manuscript. IB was involved in acquisition of data, drafting the manuscript, and critical revision of the manuscript for important intellectual content. NS was involved in analysis and interpretation of data and statistical analysis. GP was involved in critical revision of the manuscript for important intellectual content and analysis and interpretation of data. VG was involved in acquisition of data, critical revision of the manuscript for important intellectual content, and analysis and interpretation of data. ZB was involved in acquisition of data, critical revision of the manuscript for important intellectual content, and analysis and interpretation of data. DS was involved in critical revision of the manuscript for important intellectual content, obtained funding, was involved in study supervision, and approved the final version of the manuscript.

Compliance with ethical standards

Disclosures

Goran Hauser, Ivana Blazevic, Nermin Salkic, Goran Poropat, Vanja Giljaca, Zlatko Bulic, Davor Stimac has no conflicts of interest or financial ties to disclose.

Supplementary material

464_2016_5004_MOESM1_ESM.docx (16 kb)
Supplementary material 1 (DOCX 15 kb)

References

  1. 1.
    Dumonceau J, Andriulli A, Elmunzer B et al (2014) European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis—updated. Endoscopy 46:799–815CrossRefPubMedGoogle Scholar
  2. 2.
    Freeman ML, Guda NM (2004) Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc 59:845–864CrossRefPubMedGoogle Scholar
  3. 3.
    Hauser G, Milosevic M, Stimac D et al (2015) Preventing post-endoscopic retrograde cholangiopancreatography pancreatitis: what can be done? World J Gastroenterol 21:1069–1080CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Loperfido S, Ferrara F, Costamagna G (2015) Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. In: Post TW (ed) UpToDate. Waltham, MAGoogle Scholar
  5. 5.
    Anderson MA, Fisher L, Jain R (2012) Complications of ERCP. Gastrointest Endosc 75:467–473CrossRefPubMedGoogle Scholar
  6. 6.
    Donnellan F, Byrne MF (2012) Prevention of post-ERCP Pancreatitis. Gastroenterol Res Pract 2012:796751CrossRefPubMedGoogle Scholar
  7. 7.
    Banks PA, Freeman ML (2006) Practice guidelines in acute pancreatitis. Am J Gastroenterol 101:2379–2400CrossRefPubMedGoogle Scholar
  8. 8.
    Woods KE, Willingham FF (2010) Endoscopic retrograde cholangiopancreatography associated pancreatitis: a 15-year review. World J Gastrointest Endosc 2:165–178PubMedPubMedCentralGoogle Scholar
  9. 9.
    Räty S, Sand J, Pulkkinen M et al (2001) Post-ERCP pancreatitis: reduction by routine antibiotics. J Gastrointest Surg 5:339–345CrossRefPubMedGoogle Scholar
  10. 10.
    Sherman S (1994) ERCP and endoscopic sphincterotomy-induced pancreatitis. Am J Gastroenterol 89:303–305PubMedGoogle Scholar
  11. 11.
    Zheng M-H, Xia HH-X, Chen Y-P (2008) Rectal administration of NSAIDs in the prevention of post-ERCP pancreatitis: a complementary meta-analysis. Gut 57:1632–1633PubMedGoogle Scholar
  12. 12.
    Dai H-F, Wang X-W, Zhao K (2009) Role of nonsteroidal anti-inflammatory drugs in the prevention of post-ERCP pancreatitis: a meta-analysis. Hepatobiliary Pancreat Dis Int 8:11–16PubMedGoogle Scholar
  13. 13.
    Elmunzer BJ, Waljee AK, Elta GH et al (2008) A meta-analysis of rectal NSAIDs in the prevention of post-ERCP pancreatitis. Gut 57:1262–1267CrossRefPubMedGoogle Scholar
  14. 14.
    Stevenson D (1984) Diagnosis, prevention, and treatment of adverse reactions to aspirin and nonsteroidal anti-inflammatory drugs. J Allergy Clin Immunol 74:617–622CrossRefPubMedGoogle Scholar
  15. 15.
    Kowalski ML, Makowska JS, Blanca M et al (2011) Hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs)—classification, diagnosis and management: review of the EAACI/ENDA(#) and GA2LEN/HANNA*. Allergy 66:818–829CrossRefPubMedGoogle Scholar
  16. 16.
    Doña I, Blanca-López N, Cornejo-García JA et al (2011) Characteristics of subjects experiencing hypersensitivity to non-steroidal anti-inflammatory drugs: patterns of response. Clin Exp Allergy 41:86–95CrossRefPubMedGoogle Scholar
  17. 17.
    Zhao L-N, Yu T, Li C-Q et al (2014) Somatostatin administration prior to ERCP is effective in reducing the risk of post-ERCP pancreatitis in high-risk patients. Exp Ther Med 8:509–514PubMedPubMedCentralGoogle Scholar
  18. 18.
    Akshintala VS, Hutfless SM, Colantuoni E et al (2013) Systematic review with network meta-analysis: pharmacological prophylaxis against post-ERCP pancreatitis. Aliment Pharmacol Ther 38:1325–1337CrossRefPubMedGoogle Scholar
  19. 19.
    Brand M, Bizos D, O’Farrell P Jr (2010) Antibiotic prophylaxis for patients undergoing elective endoscopic retrograde cholangiopancreatography. Cochrane Database Syst Rev 6:CD007345. doi: 10.1002/14651858.CD007345.pub2 Google Scholar
  20. 20.
    Cotton PB, Lehman G, Vennes J et al (1991) Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 37:383–393CrossRefPubMedGoogle Scholar
  21. 21.
    Faul F, Erdfelder E, Buchner ALG (2009) Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods 41:1149–1160CrossRefPubMedGoogle Scholar
  22. 22.
    Harris A, Chan AC, Torres-Viera C et al (1999) Meta-analysis of antibiotic prophylaxis in endoscopic retrograde cholangiopancreatography (ERCP). Endoscopy 31:718–724CrossRefPubMedGoogle Scholar
  23. 23.
    Bai Y, Gao F, Gao J et al (2009) Prophylactic antibiotics cannot prevent endoscopic retrograde cholangiopancreatography-induced cholangitis: a meta-analysis. Pancreas 38:126–130CrossRefPubMedGoogle Scholar
  24. 24.
    Brand M, Bizos D (2008) Do patients with endovascular prostheses require prophylactic antibiotics before they undergo ERCP? Gastrointest Endosc 68:1242CrossRefPubMedGoogle Scholar
  25. 25.
    Subhani JM, Kibbler C, Dooley JS (1999) Review article: antibiotic prophylaxis for endoscopic retrograde cholangiopancreatography (ERCP). Aliment Pharmacol Ther 13:103–116CrossRefPubMedGoogle Scholar
  26. 26.
    Brandes J, Scheffer B, Lorenz-Meyer H et al (1981) ERCP: complications and prophylaxis a controlled study. Endoscopy 13:27–30CrossRefPubMedGoogle Scholar
  27. 27.
    Sotoudehmanesh R, Eloubeidi MA, Asgari AA et al (2014) A randomized trial of rectal indomethacin and sublingual nitrates to prevent post-ERCP pancreatitis. Am J Gastroenterol 109:903–909CrossRefPubMedGoogle Scholar
  28. 28.
    Mosler P, Sherman S, Marks J et al (2005) Oral allopurinol does not prevent the frequency or the severity of post-ERCP pancreatitis. Gastrointest Endosc 62:245–250CrossRefPubMedGoogle Scholar
  29. 29.
    Elmunzer BJ, Scheiman JM, Lehman GA et al (2012) A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med 366:1414–1422CrossRefPubMedPubMedCentralGoogle Scholar
  30. 30.
    Buxbaum J, Yan A, Yeh K et al (2014) Aggressive hydration with lactated Ringer’s solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol 12(303–307):e1Google Scholar
  31. 31.
    Hookey LC, RioTinto R, Delhaye M et al (2006) Risk factors for pancreatitis after pancreatic sphincterotomy: a review of 572 cases. Endoscopy 38:670–676CrossRefPubMedGoogle Scholar
  32. 32.
    Ito K, Fujita N, Kanno A et al (2011) Risk factors for post-ERCP pancreatitis in high risk patients who have undergone prophylactic pancreatic duct stenting: a multicenter retrospective study. Intern Med 50:2927–2932CrossRefPubMedGoogle Scholar
  33. 33.
    Wang P, Li Z-S, Liu F et al (2009) Risk factors for ERCP-related complications: a prospective multicenter study. Am J Gastroenterol 104:31–40CrossRefPubMedGoogle Scholar
  34. 34.
    Cheng C-L, Sherman S, Watkins JL et al (2006) Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol 101:139–147CrossRefPubMedGoogle Scholar
  35. 35.
    Cotton PB, Garrow DA, Gallagher J et al (2009) Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc 70:80–88CrossRefPubMedGoogle Scholar
  36. 36.
    DiMagno MJ, Spaete JP, Ballard DD et al (2013) Risk models for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP): smoking and chronic liver disease are predictors of protection against PEP. Pancreas 42:996–1003CrossRefPubMedPubMedCentralGoogle Scholar
  37. 37.
    Somchai A, Tuangthip P, Pimtawan W (2009) Pain score within twenty-four hours post-therapeutic endoscopic retrograde cholangiopancreatography: a comparison between diagnostic and therapeutic procedure. Gastroenterology insights 2009, volume 1:e7, pp V1:20–3Google Scholar

Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  1. 1.Department of GastroenterologyClinical Hospital Centre RijekaRijekaCroatia
  2. 2.Faculty of Medicine RijekaUniversity of RijekaRijekaCroatia
  3. 3.Faculty of Health StudiesUniversity of RijekaRijekaCroatia
  4. 4.Department of Emergency MedicineClinical Hospital Centre RijekaRijekaCroatia
  5. 5.Department of Gastroenterology and HepatologyUniversity Clinical Centre TuzlaTuzlaBosnia and Herzegovina

Personalised recommendations