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A Randomized Controlled Trial of Valdecoxib and Glyceryl Trinitrate for the Prevention of Post-ERCP Pancreatitis.
MedLine Citation:
PMID:  20717044     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
BACKGROUND: Efforts to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis have been largely unsuccessful. Cyclo-oxygenase-2 enzyme-mediated inflammatory pathway has been suggested in the pathophysiology of acute pancreatitis. Glyceryl trinitrate (GTN) might prevent post-ERCP pancreatitis by relaxing the sphincter of Oddi.
OBJECTIVE: To evaluate the efficacy of valdecoxib, a cyclo-oxygenase-2 inhibitor, and GTN transdermal patch for the prevention of post-ERCP pancreatitis.
METHODS: Patients undergoing first ERCP procedure from October 2003 to August 2005 were randomized to receive either 20 mg intravenous valdecoxib or GTN patch (10 mg/h) at the start of ERCP, or assigned to control group. The study followed CONSORT guidelines. Primary outcome measure was frequency of post-ERCP pancreatitis in the 3 groups.
RESULTS: A total of 380 patients were randomized; 121 patients in valdecoxib (group 1), 124 in GTN (group 2), and 126 in the control arm (group 3) were analyzed. There was no difference in the frequency of post-ERCP pancreatitis between the groups (12 each in groups 1 and 2, and 13 in group 3; P=0.986). None of the patients had severe pancreatitis. The frequency of post-ERCP pain and amylase levels were also similar in the 3 groups (P=0.769 and P=0.947, respectively). Pancreatic duct cannulation, cholecystectomy, difficult cannulation, and pre-cut were risk factors for pancreatitis on univariate analysis. On multivariate analysis, pancreatic duct cannulation was the only independent risk factor for pancreatitis (P≤0.001; odds ratio 5.67; 95% confidence interval: 2.76-11.63).
CONCLUSIONS: Valdecoxib and GTN were not effective for the prevention of post-ERCP pancreatitis.
Authors:
Vikram Bhatia; Vineet Ahuja; Subrat Kumar Acharya; Pramod Kumar Garg
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of clinical gastroenterology     Volume:  45     ISSN:  1539-2031     ISO Abbreviation:  J. Clin. Gastroenterol.     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-01-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7910017     Medline TA:  J Clin Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  170-6     Citation Subset:  IM    
Affiliation:
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
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