Efficacy of diclofenac in the prevention of post-ERCP pancreatitis in predominantly high-risk patients: a randomized double-blind prospective trial.
BACKGROUND
Pancreatitis is one of the major complications of ERCP and endoscopic sphincterotomy. It has been shown that nonsteriodal anti-inflammatory drugs are potent inhibitors of phospholipase A(2), activity which is increased in pancreatitis. A previous study showed reduction of post-ERCP pancreatitis with administration of rectal diclofenac.


OBJECTIVE
The aim of this study was to determine whether prophylactic oral diclofenac will reduce the incidence and the severity of ERCP-induced pancreatitis, especially in high-risk patients.


METHODS
Single-center, randomized, double-blinded, prospective study.


METHODS
Indiana University Medical Center.


METHODS
A total of 207 evaluable patients were randomized to receive either diclofenac 50 mg or placebo by mouth 30 to 90 minutes before and 4 to 6 hours after ERCP.


RESULTS
The groups were similar with regard to patient demographics and to patient and procedure risk factors for post-ERCP pancreatitis. The overall incidence of post-ERCP pancreatitis was 16.4%. It occurred in 17 of 102 patients in the control group (16.7%) and in 17 of 105 patients in diclofenac group (16.2%). The pancreatitis was graded mild in 9.8%, moderate in 5.9%, and severe 1.0% of the control group, and mild in 10.5%, moderate in 4.8%, and severe in 1.0% of the diclofenac group. In high-risk patients, the incidence of post-ERCP pancreatitis was 17.3%. It occurred in 18.0% (16/89) in the control group and in 17.8% (16/90) in the diclofenac group. There was no significant difference between the groups in the frequency or severity of post-ERCP pancreatitis in overall and high-risk patients; however, the power of the study was less than 45%.


CONCLUSIONS
Prophylactic orally administered diclofenac was not observed to affect the frequency or severity of post-ERCP pancreatitis in high-risk patients.
Cheon
Young Koog
YK
Indiana University Medical Center; Indianapolis, Indiana 46202, USA.
Cho
Kwang Bum
KB
Watkins
James L
JL
McHenry
Lee
L
Fogel
Evan L
EL
Sherman
Stuart
S
Schmidt
Suzette
S
Lazzell-Pannell
Laura
L
Lehman
Glen A
GA
D000284:Administration, Oral; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D004008:Diclofenac / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010182:Pancreatic Diseases / Q000175:diagnosis; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011322:Primary Prevention / Q000379:methods*; D011446:Prospective Studies
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac