The effect of prophylactic peripapillary administration of methylprednisolone in reducing the risk and severity of postendoscopic retrograde cholangiopancreatography pancreatitis: A double blind clinical trial

Background: The most common complication of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) is acute pancreatitis. A number of therapeutic trials have been studied due to reduce the occurrence of postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) but many of them were unsuccessful. Periampullary corticosteroid injection was proposed to use as prophylactic agents for PEP because of its anti-inflammatory property with relative low systemic side effects. Materials and Methods: By conducting a double blinded clinical trial study in a single center university hospital, all patients undergoing therapeutic or diagnostic ERCP in our gastrointestinal endoscopy ward, enrolled the study. During ERCP, we randomly assigned the patients in blocks of 40 to undergo a locally injection of methylprednisolone acetate (corticosteroid group) or saline (control group) on the major papilla and prospectively evaluated the occurrence of PEP pancreatitis in each groups. Clinical and laboratory findings of acute pancreatitis were collected by means of a validated questionnaire during the procedure and before discharge. At baseline and end of the study, were compared pancreatitis prevalence and also its severity by using Chi-square and t-test statistics. Results: The frequency of moderate to severe PEP pain was not significantly between the placebo and corticosteroid receiving group (13.7% ± 3.2% vs. 9.3% ± 2.1%, respectively; P = 0.8). There is no significant difference in the mean concentration of lipase and amylase between corticosteroid receiving group and placebo receiving group at the first, second, and third time. In the corticosteroid receiving group, 3 patients (10.3%) while in the control group, 11 patients (11.3%) developed pancreatitis. Conclusion: We found no significant difference in PEP rates and also severity between the corticosteroid and placebo groups. The mean increase in serum amylase and amylase level in pancreatitis patients and the frequency of abdominal pain were not significantly higher in the placebo group. Besides, there were no cases of severe PEP pancreatitis in either group.