Nonsteroidal anti-inflammatory drugs versus placebo for post-endoscopic retrograde cholangiopancreatography pancreatitis: a systematic review and meta-analysis

Abstract

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure for treatment of diseases that affect the biliary tree and pancreatic duct. While the therapeutic success rate of ERCP is high, the procedure can cause complications, such as acute pancreatitis (PEP), bleeding, and perforation. This meta-analysis aimed to assess the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing PEP following (ERCP).

Materials and methods We searched databases, such as MEDLINE, Embase, and Cochrane Central Library. Only randomized controlled trials (RCTs) that compared the efficacy of NSAIDs and placebo for the prevention of PEP were included. Outcomes assessed included incidence of PEP, severity of pancreatitis, route of administration, and type of NSAIDs.

Results Twenty-one RCTs were considered eligible with a total of 6854 patients analyzed. Overall, 3427 patients used NSAIDs before ERCP and 3427 did not use the drugs (control group). In the end, 250 cases of acute pancreatitis post-ERCP were diagnosed in the NSAIDs group and 407 cases in the placebo group. Risk for PEP was lower in the NSAID group (risk difference (RD): −0.05; 95 % confidence interval (CI): −0.07 to – 0.03; number need to treat (NNT), 20; P < 0.05). Use of NSAIDs effectively prevented mild pancreatitis compared with use of placebo (2.5 % vs. 4.1 %; 95 % CI, −0.05 to – 0.01; NNT, 33; P < 0.05), but the information on moderate and severe PEP could not be completely elucidated. Only rectal administration reduced incidence of PEP (6.8 % vs. 13 %; 95 % CI, −0.10 to – 0.04; NNT, 20; P < 0.05). Furthermore, only diclofenac or indomethacin use was effective in preventing PEP.

Conclusions Rectal administration of diclofenac and indomethacin significantly reduced risk of developing mild PEP. Further RCTs are needed to compare efficacy between NSAID administration pathways in prevention of PEP after ERCP.

• References

• 1 Sajid MS, Khawaja AH, Sayegh M. et al. Systematic review and meta-analysis on the prophylactic role of non-steroidal anti-inflammatory drugs to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis. World J Gastrointest Endosc 2015; 7: 1341-1349
• 2 Zhao ZH, Hu LH, Ren HB. et al. Incidence and risk factors for post-ERCP pancreatitis in chronic pancreatitis. Gastrointest Endosc 2017; 86: 519-524.e1
• 3 Sun HL, Han B, Zhai HP. et al. Rectal NSAIDs for the prevention ofm post-ERCP pancreatitis: a meta-analysis of randomized controlled trials. Surgeon 2014; 12: 141-147
• 4 Freeman ML, DiSario JA, Nelson DB. et al. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc 2001; 54: 425-434
• 5 Vandervoort J, Soetikno RM, Tham TC. et al. Risk factors for complications after performance of ERCP. Gastrointest Endosc 2002; 56: 652-656
• 6 Ferreira Ade F, Bartelega JA, Urbano HC. et al. Acute pancreatitis gravity predictive factors: which and when to use them?. Arq Bras Cir Dig 2015; 28: 207-211
• 7 Nesvaderani M, Eslick GD, Vagg D. et al. Epidemiology, aetiology and outcomes of acute pancreatitis: A retrospective cohort study. Int J Surg 2015; 23: 68-74
• 8 Bhatia V, Ahuja V, Acharya SK. et al. A randomized controlled trial of valdecoxib and glyceryl trinitrate for the prevention of post-ERCP pancreatitis. J Clin Gastroenterol 2011; 45: 170-176
• 9 Mäkelä A, Kuusi T, Schröder T. Inhibition of serum phospholipase-A2 in acute pancreatitis by pharmacological agents in vitro. Scand J Clin Lab Invest 1997; 57: 401-407
• 10 Choudhary A, Bechtold ML, Arif M. et al. Pancreatic stents for prophylaxis against post-ERCP pancreatitis: a meta-analysis and systematic review. Gastrointest Endosc 2011; 73: 275-282
• 11 Kubiliun NM, Adams MA, Akshintala VS. United States Cooperative for Outcomes Research in Endoscopy (USCORE). et al. Evaluation of Pharmacologic Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: A Systematic Review. Clin Gastroenterol Hepatol 2015; 13: 1231-1239 ; quiz e70-1
• 12 Brust R, Thomson AB, Wensel RH. et al. Pancreatic injury following ERCP. Failure of prophylactic benefit of Trasylol. Gastrointest Endosc 1977; 24: 77-79
• 13 Olazabal A, Nascimento L. Effects of indomethacin, aspirin, and fat-free diet on experimental pancreatitis in the rat. J Lab Clin Med 1980; 96: 570-576
• 14 Guerra M. Toxicity of indomethacin. Report of a case of acute pancreatitis. JAMA 1967; 200: 552-553
• 15 Moher D, Liberati A, Tetzlaff J. et al. The PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 2009; 6: e1000097 [https://doi.org/10.1371/journal.pmed.1000097]
• 16 Jadad AR, Moore RA, Carroll D. et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996; 17: 1-12
• 17 Elmunzer BJ, Scheiman JM, Lehman GA. et al. U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med 2012; 366: 1414-1422
• 18 Lua GW, Muthukaruppan R, Menon J. Can rectal diclofenac prevent post endoscopic retrograde cholangiopancreatography pancreatitis?. Dig Dis Sci 2015; 60: 3118-3123
• 19 Park SW, Chung MJ, Oh TG. et al. Intramuscular diclofenac for the prevention of post-ERCP pancreatitis: a randomized trial. Endoscopy 2015; 47: 33-39
• 20 Ishiwatari H, Urata T, Yasuda I. et al. No benefit of oral diclofenac on post-endoscopic retrograde cholangiopancreatography pancreatitis. Dig Dis Sci 2016; 61: 3292-3301
• 21 Leerhøy B, Nordholm-Carstensen A, Novovic S. et al. Effect of body weight on fixed dose of diclofenac for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Scand J Gastroenterol 2016; 51: 1007-1012
• 22 Hauser G, Blažević I, Salkić N. et al. Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial. Surg Endosc 2017; 31: 602-610
• 23 Senol A, Saritas U, Demirkan H. Efficacy of intramuscular diclofenac and fluid replacement in prevention of post-ERCP pancreatitis. World J Gastroenterol 2009; 15: 3999-4004
• 24 Khoshbaten M, Khorram H, Madad L. et al. Role of diclofenac in reducing post-endoscopic retrograde cholangiopancreatography pancreatitis. J Gastroenterol Hepatol 2008; 23: e11-16
• 25 Uçar R, Biyik M, Uçar E. et al. Rectal or intramuscular diclofenac reduces the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography. Turk J Med Sci 2016; 46: 1059-1063
• 26 Otsuka T, Kawazoe S, Nakashita S. et al. Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial. J Gastroenterol 2012; 47: 912-917
• 27 Murray B, Carter R, Imrie C. et al. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Gastroenterology 2003; 124: 1786-1791
• 28 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
• 29 Patai Á, Solymosi N, Patai ÁV. Effect of rectal indomethacin for preventing post-ERCP pancreatitis depends on difficulties of cannulation: results from a randomized study with sequential biliary intubation. J Clin Gastroenterol 2015; 49: 429-437
• 30 Montaño Loza A, Rodríguez Lomelí X, García Correa JE. et al. Effect of the administration of rectal indomethacin on amylase serum levels after endoscopic retrograde cholangiopancreatography, and its impact on the development of secondary pancreatitis episodes. Rev Esp Enferm Dig 2007; 99: 330-336
• 31 Andrade-Dávila VF, Chávez-Tostado M, Dávalos-Cobián C. et al. Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial. BMC Gastroenterol 2015; 15: 85
• 32 Levenick JM, Gordon SR, Fadden LL. et al. Rectal indomethacin does not prevent post-ercp pancreatitis in consecutive patients. Gastroenterology 2016; 150: 911-917 ; quiz e19
• 33 Döbrönte Z, Szepes Z, Izbéki F. et al. Is rectal indomethacin effective in preventing of post-endoscopic retrograde cholangiopancreatography pancreatitis?. World J Gastroenterol 2014; 20: 10151-10157
• 34 Hosseini M, Shalchiantabrizi P, Yektaroudy K. et al. Prophylactic effect of rectal indomethacin administration, with and without intravenous hydration, on development of endoscopic retrograde cholangiopancreatography pancreatitis episodes: a randomized clinical trial. Arch Iran Med 2016; 19: 538-543
• 35 Mansour-Ghanaei F, Joukar F, Taherzadeh Z. et al. Suppository naproxen reduces incidence and severity of post-endoscopic retrograde cholangiopancreatography pancreatitis: Randomized controlled trial. World J Gastroenterol 2016; 22: 5114-5121
• 36 de Quadros Onófrio F, Lima JCP, Watte G. et al. Prophylaxis of pancreatitis with intravenous ketoprofen in a consecutive population of ERCP patients: a randomized double-blind placebo-controlled trial. Surg Endosc 2017; 31: 2317-2324
• 37 Dumonceau JM, Andriulli A, Elmunzer BJ. European Society of Gastrointestinal Endoscopy. et al. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy 2014; 46: 799-815
• 38 Chandrasekhara V, Khashab MA. ASGE Standards of Practice Committee. et al. Adverse events associated with ERCP. Gastrointest Endosc 2017; 85: 32-47
• 39 Yokoe M, Takada T, Mayumi T. et al. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci 2015; 22: 405-432
• 40 Shi N, Deng L, Altaf K. et al. Rectal indomethacin for the prevention of post-ERCP pancreatitis: A meta-analysis of randomized controlled trials. Turk J Gastroenterol 2015; 26: 236-240
• 41 Li X, Tao LP, Wang CH. Effectiveness of nonsteroidal anti-inflammatory drugs in prevention of post-ERCP pancreatitis: a meta-analysis. World J Gastroenterol 2014; 20: 12322-12329
• 42 de Moura ET, de Moura EG, Bernardo W. et al. Guide wire-assisted cannulation versus conventional contrast to prevent pancreatitis. A systematic review and meta-analysis based on randomized control trials. Rev Gastroenterol Peru 2016; 36: 308-319
• 43 Hwang HJ, Guidi MA, Curvale C. et al. Post-ERCP pancreatitis: early precut or pancreatic duct stent? A multicenter, randomized-controlled trial and cost-effectiveness analysis. Rev Esp Enferm Dig 2017; 109: 174-179