Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial, in Post ERCP Pancreatitis

Yasser Abu-Safieh^1, , Raed Altiti¹ and Mohammad Lobadeh¹

¹Specialized Arab Hospital, affiliated with school of Medicine, An Najah University, Nablus, Palestine

Cite this paper

Yasser Abu-Safieh, Raed Altiti and Mohammad Lobadeh. Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial, in Post ERCP Pancreatitis. American Journal of Clinical Medicine Research. 2014; 2(2):43-46. doi: 10.12691/AJCMR-2-2-1

Abstract

Background and Study Aim: In several studies non-steroidal anti inflammatory drugs (NSAIDs) showed reduction of post (ERCP) pancreatitis incidence and severity. Our aim is to study the effect of NSAIDs in reducing post ERCP pancreatitis (PEP). Patients and Methods: A double blind placebo controlled study was conducted, patients who underwent ERCP in Specialized Arab Hospital (SAH), collected over one year, from June 2012 to June 2013 . Patients were randomized by an endoscopy nurse to receive IM Diclofenac 75 mg, or IM isotonic saline 3 ml as placebo. 12 hours after completing the procedure all patients were evaluated for abdominal pain and serum amylase. Results: The total number of patients was 199 patients, 17 patients were excluded, 182 patients completed the study, diclofenac group (89), placebo (93), the two groups were comparable for the following: age, sex, ERCP finding, pancreatic duct cannulation, failure of common bile duct (CBD) cannulation, number of pancreatic duct cannulation, ERCP time, sphincterotomy, and stenting. The overall incidence of pancreatitis was (18/182) 10%, (6/89) 6.9% for the diclofenac group and (12/93) 12.9% for the placebo group. There was no significant difference in the incidence of pancreatitis between the two groups; the P value was 0.164. In all the cases in which pancreatitis occurs, it was mild or moderate; there was no severe pancreatitis among the two groups. But in subgroup analysis the frequency of pancreatitis in patients with multiple pancreatic duct cannulation was significantly lower in the diclofenac group than in control group with p value = 0.021. Conclusion: Intramuscular diclofenac does not lower PEP rate or severity. But it significantly decreased PEP in patients with multiple pancreatic duct cannulations.

Keywords

diclofenac, ERCP, pancreatitis

Copyright

This work is licensed under a Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

References

[1]	Lieb II JG, Draganov PV. Early successes and late failures in the prevention of post endoscopic retrograde cholangiopancreatography pancreatitis. World J Gastroenterol 2007 July 14; 13 (26): 3567-3574.
[2]	Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996; 335: 909-918.
[3]	Cheon YK, Cho KB, Watkins JL, McHenry L, Fogel EL,Sherman S, Lehman GA. Frequency and severity of post- ERCP pancreatitis correlated with extent of pancreatic ductalopacification. Gastrointest Endosc 2007; 65: 385-393.
[4]	Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG,Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors. for post-ERCP pancreatitis: a prospective, multicenter study.Gastrointest Endosc 2001; 54: 425-434.
[5]	Rabenstein T, Framke B, Martus P, et al. Method related riskfactors for complications of endoscopic sphincterotomy. Aprospective study (abstract). Gastrointest Endosc 1999; 49: AB
[6]	Cheng CL, Sherman S, Watkins JL, Barnett J, Freeman M, Geenen J, Ryan M, Parker H, Frakes JT, Fogel EL, Silverman WB, Dua KS, Aliperti G, Yakshe P, Uzer M, Jones W, Goff J, Lazzell-Pannell L, Rashdan A, Temkit M, Lehman GA. Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol. 2006 Jan; 101 (1): 139-47.
[7]	González-Ojeda A 1, Dávalos-Cobian C 2, Andalón-Dueñas E 1, Chávez-Tostado M 1, Espinosa-Partida A 1, Fuentes-Orozco C 1. Endoscopic Retrograde Cholangiopancreatography-Related Acute Pancreatitis – Identification, Prophylaxis and Treatment.
[8]	Döbrönte Z. Endoscopic Retrograde Cholangiopancreatography (ERCP) Related Acute Pancreatitis.
[9]	Altug S, Ulku S, Halil D. Efficacy of intramuscular diclofenac and fluid replacement in prevention of post-ERCP pancreatitis. World J Gastroenterol 2009 August 28; 15 (32): 3999-4004 wjg@wjgnet.com World Journal of Gastroenterology ISSN 1007-9327.
[10]	Ülkü S, Yücel Ü, Todd H. Prevention of post-ERCP pancreatitis. Turk J Gastroenterol 2011; 22 (5): 449-463.
[11]	John G, Peter V. Early successes and late failures in the prevention of post endoscopic retrograde cholangiopancreatography. World J Gastroenterol 2007 July 14; 13 (26): 3567-3574.
[12]	Pier T. Simple measures to prevent post-ERCP pancreatitis. Gut 2008; 57: 1197-1198.
[13]	Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, KorsnesSJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med 2012; 366: 1414-1422.
[14]	Murray B, Carter R, Imrie C, Evans S, O’Suilleabhain C. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Gastroenterology 2003; 124: 1786-1791.
[15]	Khoshbaten M, Khorram H, Madad L, Ehsani Ardakani MJ, Farzin H, Zali MR. Role of diclofenac in reducing post-endoscopic retrograde cholangiopancreatography pancreatitis. J Gastroenterol Hepatol. 2008; 23: e11-e16.
[16]	Sotoudehmanesh R, Khatibian M, Kolahdoozan S, Ainechi S, Malboosbaf R, Nouraie M. Indomethacin may reduce the incidence and severity of acute pancreatitis after ERCP. Am J Gastroenterol. 2007; 102: 978-983.
[17]	Montaño Loza A, Rodríguez Lomelí X, García Correa JE, Dávalos Cobián C, Cervantes Guevara G, Medrano Muñoz F, Fuentes Orozco C, González Ojeda A. [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.
[18]	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: 1126-32.
[19]	Montano Loza A, García Correa J, González Ojeda A, Fuentes Orozco C, Dá valos Cobián C, Rodríguez Lomelí X. Prevention of hyperamilasemia and pancreatitis after endoscopic retrograde cholangiopancreatography with rectal administration of indomethacin 27. Kapral C, Duller C, Wewalka F, Kerstan E, Vogel W, Schreiber F. Case volume and outcome of endoscopic retrograde cholangiopancreatography: results of a nationwide Austrian benchmarking project. Endoscopy. 2008; 40 (8): 625-30.
[20]	Elmunzer BJ, Waljee AK, Elta GH, et al. A meta-analysis of rectal NSAIDs in the prevention of post-ERCP pancreatitis. Gut 2008; 57: 1262-7.