Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial - 23/08/11
European Post-ERCP Pancreatitis Preventing Study Group
Reprint requests: Camilla Nøjgaard, MD, Hvidovre Hospital, Kettegårds Alle 30, 2650 Hvidovre, Denmark.Hvidovre, Glostrup, Gentofte, Copenhagen, Denmark, Malmö, Halmstad, Sweden, Marseille, France, Fredrikstad, Oslo, Haugesund, Norway
Abstract |
Objective |
Acute pancreatitis is the most dreaded complication of ERCP. Two studies have shown a significant effect of glyceryl nitrate (GN) in preventing post-ERCP pancreatitis (PEP). We wanted to evaluate this promising effect in a larger study with a realistically precalculated incidence of PEP.
Design/Patients |
A randomized, double-blind, placebo-controlled multicenter study including patients from 14 European centers was performed. A total of 820 patients were entered; 806 were randomized.
Intervention |
The active drug was transdermal GN (Discotrine/Minitran, 3M Pharma) 15 mg/24 hours; placebo (PL) was an identical-looking patch applied before ERCP. A total of 401 patients received GN; 405 received PL.
Results |
Forty-seven patients had PEP (5.8%), 18 (4.5%) in the GN group and 29 (7.1%) in the PL group. The relative risk reduction of PEP in the GN group of 36% (95% CI, 11%-65%) compared with the PL group was not statistically significant (P = .11). Thirteen had mild pancreatitis (4 in the GN group, 9 in the PL group), 26 had moderate pancreatitis (9 in the GN group, 17 in the PL group), and 8 had severe pancreatitis (5 in the GN group, 3 in the PL group). Headache (P < .001) and hypotension (P = .006) were more common in the GN group. Significant variables predictive of PEP were not having biliary stones extracted; hypotension after ERCP; morphine, propofol, glucagon, and general anesthesia during the procedure; or no sufentanil during the procedure.
Conclusions |
The trial showed no statistically significant preventive effect of GN on PEP. Because of a considerable risk of a type II error, an effect of GN may have been overlooked. (ClinicalTrials.gov ID: NCT00121901.)
Il testo completo di questo articolo è disponibile in PDF.Abbreviations : GN, PEP, PL
Mappa
| DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. |
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| The EPEPPS-group, contributors: Ulrich Bang, Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark; Finn Møller Pedersen and Ove B Schaffalitzky de Muckadell, Department of Internal Medicine S, Odense University Hospital, Odense, Denmark; Taran Søberg, Division of Gastroenterology, Østfold County Hospital Fredrikstad, Fredrikstad, Norway; Lars Karlsen and Tom Glomsaker, Department of Internal Medicine and Surgery, Stavanger University Hospital, Stavanger, Norway; Peter Vilman, Department of Surgery D, Gentofte Hospital, Gentofte, Denmark; Trine Stigaard Larsen, Mikkel Westen, Svend Schulze, Department of Internal Medicine M and Surgery D, Glostrup Hospital, Glostrup, Denmark; Hans Kromann Andersen and Peter Vestergaard, Department of Gastroenterology and Surgery, Roskilde County Hospital Køge, Denmark; Mette Skov, Mark James McCullagh, Lars Bo Svendsen, Department of Gastroenterological Surgery CTX, Rigshospitalet, Copenhagen, Denmark; Nathalie Lesavre, Center of Clinical Investigation, North Hospital, Marseille, France; Marc Barthet, Department of Gastroenterology, North Hospital, Marseille, France; Per Almquist, Ervin Toth, Department of Surgery, Malmö University Hospital, Malmö, Sweden; Bengt Börjesson and Hans Högström, Department of Surgery, Halmstad Hospital, Halmstad, Sweden; José Sahel, Department of Gastroenterology, Conception Hospital, Marseille, France; Martin Theil Jensen, Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark. |
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| If you want to chat with an author of this article, you may contact her at mille@dadlnet.dk. |
Vol 69 - N° 6
P. e31-e37 - maggio 2009 Ritorno al numero
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