A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis

New England Journal of Medicine

Volumn 366, Issue 15, 2012, Pages 1414-1422

  Elmunzer, B Joseph ^a   Scheiman, James M ^a   Lehman, Glen A ^c   Chak, Amitabh ^d   Mosler, Patrick ^e   Higgins, Peter D R ^a   Hayward, Rodney A ^a,b   Romagnuolo, Joseph ^f   Elta, Grace H ^a   Sherman, Stuart ^c   Waljee, Akbar K ^a,b   Repaka, Aparna ^d   Atkinson, Matthew R ^d   Cote, Gregory A ^c   Kwon, Richard S ^a   McHenry, Lee ^c   Piraka, Cyrus R ^a   Wamsteker, Erik J ^a   Watkins, James L ^c   Korsnes, Sheryl J ^a   Schmidt, Suzette E ^c   Turner, Sarah M ^e   Nicholson, Sylvia ^e   Fogel, Evan L ^c   more..

^a UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^b VA ANN ARBOR HEALTHCARE SYSTEM   (United States)

^c INDIANA UNIVERSITY MEDICAL CENTER   (United States)

^d UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^e UNIVERSITY OF KENTUCKY MEDICAL CENTER   (United States)

^f MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INDOMETACIN; PANCREAS ENZYME; PLACEBO;

ABDOMINAL PAIN; ADULT; ARTICLE; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DIGESTIVE SYSTEM PERFORATION; DISEASE COURSE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY; ENZYME BLOOD LEVEL; FEMALE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL INFECTION; HEART INFARCTION; HIGH RISK PATIENT; HOSPITALIZATION; HUMAN; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PANCREATITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; RISK REDUCTION; SINGLE DRUG DOSE; TREATMENT OUTCOME; VATER PAPILLA STENOSIS;

EID: 84859526085     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1111103     Document Type: Article

References (22)

1. Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc 2004;59:845-64. (Pubitemid 38879313)
2. Freeman ML, Nelson DB, Sherman S, et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996;335: 909-18. (Pubitemid 26314443)
3. National inpatient sample - Healthcare Cost and Utilization Project. Rockville, MD: Agency for Healthcare Research and Quality (http://hcupnet.ahrq. gov).
4. Gross V, Leser HG, Heinisch A, et al. Inflammatory mediators and cytokines - new aspects of the pathophysiology and assessment of severity of acute pancreatitis? Hepatogastroenterology 1993;40:522- 30.
5. Mäkelä A, Kuusi T, Schröder T. Inhibition of serum phospholipase-A2 in acute pancreatitis by pharmacologic agents in vitro. Scand J Clin Lab Invest 1997;57:401-8.
6. Murray B, Carter R, Imrie C, Evans S, O'Suilleabhain C. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Gastroenterology 2003;124:1786-91. (Pubitemid 36666775)
7. 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; 102:978-83.
8. Khoshbaten M, Khorram H, Mamad L, Ehsani Ardakani MJ, Farzin H, Zali MR. Role of diclofenac in reducing post-endoscopic retrograde cholangiopancreatography pancreatitis. J Gastroenterol Hepatol 2008;23(7):e11-e16. (Pubitemid 352019420)
9. Montaño Loza A, Rodríguez Lomeli X, García Correa JE, et al. Effect of rectal administration of indomethacin on amylase serum levels after endoscopic retrograde cholangiopancreatography, and its impact on the development of secondary pancreatitis episodes. Rev Esp Enferm Dig 2007;99:330-6. (In Spanish.)
10. 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;57:1262-7.
11. Dumonceau JM, Rigaux J, Kahaleh M, Gomez CM, Vandermeeren A, Devière J. Prophylaxis of post-ERCP pancreatitis: a practice survey. Gastrointest Endosc 2010; 71:934-9.
12. Andriulli A, Leandro G, Niro G, et al. Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis. Gastrointest Endosc 2000;51:1-7. (Pubitemid 30051601)
13. Andriulli A, Leandro G, Federici T, et al. Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated metaanalysis. Gastrointest Endosc 2007;65: 624-32. (Pubitemid 46442832)
14. Tarnasky PR, Palesch YY, Cunningham JT, Mauldin PD, Cotton PB, Hawes RH. Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction. Gastroenterology 1998;115:1518-24. (Pubitemid 28546003)
15. Fazel A, Quadri A, Catalano MF, Meyerson SM, Geenen JE. Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study. Gastrointest Endosc 2003;57:291-4. (Pubitemid 36350781)
16. Singh P, Das A, Isenberg G, et al. Does prophylactic pancreatic stent placement reduce the risk of post-ERCP pancreatitis? A meta-analysis of controlled trials. Gastrointest Endosc 2004;60:544-50. (Pubitemid 39311536)
17. Freeman ML. Pancreatic stents for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Clin Gastroenterol Hepatol 2007;5:1354-65. (Pubitemid 350019065)
18. van Der Marel CD, Anderson BJ, Rømsing J, Jacqz-Aigrain E, Tibboel D. Diclofenac and metabolite pharmacokinetics in children. Paediatr Anaesth 2004; 14:443-51. (Pubitemid 38758661)
19. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383-93.
20. Mallery JS, Baron TH, Dominitz JA, et al. Complications of ERCP. Gastrointest Endosc 2003;57:633-8.
21. Kent DM, Rothwell PM, Ioannidis JP, Altman DG, Hayward RA. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal. Trials 2010;11:85-95.
22. Nelson DB, Freeman ML. Major hemorrhage from endoscopic sphincterotomy: risk factor analysis. J Clin Gastroenterol 1994;19:283-7. (Pubitemid 24371048)