Document Detail


Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial.
MedLine Citation:
PMID:  19410035     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.).
Authors:
Camilla Nøjgaard; Mads Hornum; Margarita Elkjaer; Claes Hjalmarsson; Laurent Heyries; Truls Hauge; Kåre Bakkevold; Per Kragh Andersen; Peter Matzen;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Gastrointestinal endoscopy     Volume:  69     ISSN:  1097-6779     ISO Abbreviation:  Gastrointest. Endosc.     Publication Date:  2009 May 
Date Detail:
Created Date:  2009-05-04     Completed Date:  2009-08-06     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0010505     Medline TA:  Gastrointest Endosc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  e31-7     Citation Subset:  IM    
Affiliation:
Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00121901
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MeSH Terms
Descriptor/Qualifier:
Administration, Cutaneous
Adolescent
Adult
Aged
Aged, 80 and over
Cholangiopancreatography, Endoscopic Retrograde*
Double-Blind Method
Female
Humans
Male
Middle Aged
Nitroglycerin / administration & dosage*,  adverse effects
Pancreatitis, Acute Necrotizing / etiology,  prevention & control*
Risk
Vasodilator Agents / administration & dosage*,  adverse effects
Young Adult
Chemical
Reg. No./Substance:
0/Vasodilator Agents; 55-63-0/Nitroglycerin
Investigator
Investigator/Affiliation:
Ulrich Bang / ; Finn Møller Pedersen / ; Ove B Schaffalitzky de Muckadell / ; Taran Søberg / ; Lars Karlsen / ; Tom Glomsaker / ; Peter Vilman / ; Trine Stigaard Larsen / ; Mikkel Westen / ; Svend Schulze / ; Hans Kromann Andersen / ; Peter Vestergaard / ; Mette Skov / ; Mark James McCullagh / ; Lars Bo Svendsen / ; Nathalie Lesavre / ; Marc Barthet / ; Per Almquist / ; Ervin Toth / ; Bengt Börjesson / ; Hans Högström / ; José Sahel / ; Martin Theil Jensen /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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