A randomized controlled trial of valdecoxib and glyceryl trinitrate for the prevention of post-ERCP pancreatitis.
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.
Bhatia
Vikram
V
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
Ahuja
Vineet
V
Acharya
Subrat Kumar
SK
Garg
Pramod Kumar
PK
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000379:methods; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D005996:Nitroglycerin / Q000008:administration & dosage / Q000627:therapeutic use*; D010195:Pancreatitis / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D009803:Sphincter of Oddi / Q000187:drug effects; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult; D000096926:Benzenesulfonamides
D052246:Cyclooxygenase 2 Inhibitors; D007555:Isoxazoles; D005996:Nitroglycerin; D013449:Sulfonamides; D014665:Vasodilator Agents; C406224:valdecoxib; D000096926:Benzenesulfonamides