The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
권호 표지
DOI QR코드

DOI QR Code

Oral udenafil and aceclofenac for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: a randomized multicenter study

  • Lee, Tae Yoon (Division of Gastroenterology, Department of Internal Medicine, Konkuk University School of Medicine) ;
  • Choi, Jung Sik (Division of Gastroenterology, Department of Internal Medicine, Inje University Busan Paik Hospital) ;
  • Oh, Hyoung-Chul (Division of Gastroenterology, Department of Internal Medicine, Chung-Ang University College of Medicine) ;
  • Song, Tae Jun (Division of Gastroenterology, Department of Internal Medicine, Inje University Ilsan Paik Hospital) ;
  • Do, Jae Hyuk (Division of Gastroenterology, Department of Internal Medicine, Chung-Ang University College of Medicine) ;
  • Cheon, Young Koog (Division of Gastroenterology, Department of Internal Medicine, Konkuk University School of Medicine)
  • Received : 2014.06.20
  • Accepted : 2014.09.26
  • Published : 2015.09.01
⟨ Previous Next ⟩

Abstract

Background/Aims: Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Combination therapy with oral udenafil and aceclofenac may reduce the occurrence of post-ERCP pancreatitis by targeting different pathophysiological mechanisms. We investigated whether combining udenafil and aceclofenac reduced the rates of post-ERCP pancreatitis. Methods: A prospective, randomized, double-blind, placebo-controlled, multicenter study was conducted in four academic medical centers. Between January 2012 and June 2013, a total of 216 patients who underwent ERCP were analyzed for the occurrence of post-ERCP pancreatitis. Patients were determined to be at high risk for pancreatitis based on validated patient and procedure-related risk factors. Results: Demographic features, indications for ERCP, and therapeutic procedures were similar in each group. There were no significant differences in the rate (15.8% [17/107] vs. 16.5% [18/109], p = 0.901) and severity of post-ERCP pancreatitis between the udenafil/aceclofenac and placebo groups. One patient in each group developed severe pancreatitis. Multivariate analyses indicated that suspected dysfunction of the sphincter of Oddi and endoscopic papillary balloon dilation without sphincterotomy were associated with post-ERCP pancreatitis. Conclusions: Combination therapy with udenafil and aceclofenac is not effective for the prevention of post-ERCP pancreatitis.

Keywords

References

  1. Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc 2004;59:845-864. https://doi.org/10.1016/S0016-5107(04)00353-0
  2. Oh HC, Cheon YK, Cho YD, Do JH. Use of udenafil is not associated with a reduction in post-ERCP pancreatitis: results of a randomized, placebo-controlled, multicenter trial. Gastrointest Endosc 2011;74:556-562. https://doi.org/10.1016/j.gie.2011.04.047
  3. 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. https://doi.org/10.1056/NEJMoa1111103
  4. 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. https://doi.org/10.1016/j.gie.2010.10.039
  5. Cheon YK. Can postendoscopic retrograde cholangiopancreatography pancreatitis be prevented by a pharmacological approach? Korean J Intern Med 2013;28:141-148. https://doi.org/10.3904/kjim.2013.28.2.141
  6. Gross V, Leser HG, Heinisch A, Scholmerich J. Inflammatory mediators and cytokines: new aspects of the pathophysiology and assessment of severity of acute pancreatitis? Hepatogastroenterology 1993;40:522-530.
  7. Makela A, Kuusi T, Schroder T. Inhibition of serum phos-pholipase-A2 in acute pancreatitis by pharmacological agents in vitro. Scand J Clin Lab Invest 1997;57:401-407. https://doi.org/10.3109/00365519709084587
  8. Ding X, Chen M, Huang S, Zhang S, Zou X. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc 2012;76:1152-1159. https://doi.org/10.1016/j.gie.2012.08.021
  9. Hogan WJ, Sherman S, Pasricha P, Carr-Locke D. Sphincter of Oddi manometry. Gastrointest Endosc 1997;45:342-348.
  10. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383-393. https://doi.org/10.1016/S0016-5107(91)70740-2
  11. 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. https://doi.org/10.1016/S0016-5107(02)70178-8
  12. Cheon YK, Cho YD, Moon JH, et al. Effects of vardenafil, a phosphodiesterase type-5 inhibitor, on sphincter of Oddi motility in patients with suspected biliary sphincter of Oddi dysfunction. Gastrointest Endosc 2009;69:1111-1116. https://doi.org/10.1016/j.gie.2008.07.014
  13. 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. https://doi.org/10.1016/S0016-5085(03)00384-6
  14. Andriulli A, Solmi L, Loperfido S, et al. Prophylaxis of ERCP-related pancreatitis: a randomized, controlled trial of somatostatin and gabexate mesylate. Clin Gastroenterol Hepatol 2004;2:713-718. https://doi.org/10.1016/S1542-3565(04)00295-2
  15. Thomopoulos KC, Pagoni NA, Vagenas KA, Margaritis VG, Theocharis GI, Nikolopoulou VN. Twenty-four hour prophylaxis with increased dosage of octreotide reduces the incidence of post-ERCP pancreatitis. Gastrointest Endosc 2006;64:726-731. https://doi.org/10.1016/j.gie.2006.03.934
  16. Elmunzer BJ, Waljee AK, Elta GH, Taylor JR, Fehmi SM, Higgins PD. A meta-analysis of rectal NSAIDs in the prevention of post-ERCP pancreatitis. Gut 2008;57:1262-1267. https://doi.org/10.1136/gut.2007.140756
  17. 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. https://doi.org/10.1016/j.gie.2007.04.012
  18. van der Marel CD, Anderson BJ, Romsing J, Jacqz-Aigrain E, Tibboel D. Diclofenac and metabolite pharmacokinetics in children. Paediatr Anaesth 2004;14:443-451. https://doi.org/10.1111/j.1460-9592.2004.01232.x

Cited by

  1. The Prevention and Management of Post-ERCP Pancreatitis vol.21, pp.2, 2015, https://doi.org/10.15279/kpba.2016.21.2.68
  2. Post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review for prevention and treatment vol.25, pp.29, 2015, https://doi.org/10.3748/wjg.v25.i29.4019
  3. Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis with rectal non-steroidal anti-inflammatory drugs vol.35, pp.3, 2015, https://doi.org/10.3904/kjim.2020.069
  4. Pharmachologic Prophylaxis for Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis vol.26, pp.3, 2015, https://doi.org/10.15279/kpba.2021.26.3.148
  5. Gender differences and dose proportionality in the toxicokinetics of udenafil and its active metabolite following oral administration in rodents vol.410, pp.None, 2015, https://doi.org/10.1016/j.taap.2020.115339