| Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial. | |
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MedLine Citation:
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PMID: 19410035 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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.). |
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Authors:
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Camilla Nøjgaard; Mads Hornum; Margarita Elkjaer; Claes Hjalmarsson; Laurent Heyries; Truls Hauge; Kåre Bakkevold; Per Kragh Andersen; Peter Matzen; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: Gastrointestinal endoscopy Volume: 69 ISSN: 1097-6779 ISO Abbreviation: Gastrointest. Endosc. Publication Date: 2009 May |
Date Detail:
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Created Date: 2009-05-04 Completed Date: 2009-08-06 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0010505 Medline TA: Gastrointest Endosc Country: United States |
Other Details:
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Languages: eng Pagination: e31-7 Citation Subset: IM |
Affiliation:
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Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00121901 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Vasodilator Agents; 55-63-0/Nitroglycerin |
| Investigator | |
Investigator/Affiliation:
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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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