Efficacy of diclofenac in the prevention of post-ERCP pancreatitis in predominantly high-risk patients: a randomized double-blind prospective trial

Gastrointest Endosc. 2007 Dec;66(6):1126-32. doi: 10.1016/j.gie.2007.04.012.


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.

Design: Single-center, randomized, double-blinded, prospective study.

Setting: Indiana University Medical Center.

Patients: 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Diclofenac / administration & dosage*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pancreatic Diseases / diagnosis
  • Pancreatitis / epidemiology
  • Pancreatitis / etiology
  • Pancreatitis / prevention & control*
  • Primary Prevention / methods*
  • Prospective Studies


  • Anti-Inflammatory Agents, Non-Steroidal
  • Diclofenac