PRETREATMENT WITH METHYLPREDNISOLONE TO PREVENT ERCP-INDUCED PANCREATITIS - A RANDOMIZED, MULTICENTER, PLACEBO-CONTROLLED CLINICAL-TRIAL

Objective: Pancreatitis remains the major complication of endoscopic r etrograde cholangiopancreatography (ERCP). Uncontrolled data suggest a lower incidence of pancreatitis in patients with a history of iodine sensitivity when given pretreatment with corticosteroids. We conducted a clinical trial to assess the efficacy of a commonly prescribed cort icosteroid, methylprednisolone, to prevent ERCP-induced pancreatitis. Methods: Patients were entered into a randomized, multicenter, double- blind, placebo-controlled study of intravenous methylprednisolone (125 mg) versus a saline placebo immediately before the ERCP. All patients were evaluated for early and late complications. Results: Two hundred eighty-six patients were randomized. Thirty-one randomized patients w ere excluded for technical reasons at the time of ERCP. Overall, the i ncidence of pancreatitis was 16 of 129 (12.4%, 95% CI: 6.7-18.1%) in t he methylprednisolone group and 11 of 126 (8.7%, 95% CI: 4.4-15.1%) in the placebo group, which was not significantly different (p = 0.34). Although there was a higher rate of sphincterotomy performed in the me thylprednisolone group compared to the control group (31.8% vs 16.8%, p = 0.005), the incidence of pancreatitis was not different when patie nts undergoing sphincterotomy were analyzed separately (13.6% in the m ethylprednisolone group and 9.6% in the placebo group, p = 0.50). Ther e was no significant difference between the two groups for those with ERCP-induced pancreatitis in hospital length of stay (p = 0.22), days of parenteral analgesia (p = 0.09), or days of parenteral nutrition (p = 0.15). Conclusion: Intravenous methylprednisolone is not beneficial in preventing ERCP-induced pancreatitis. (C) 1998 by Am. Cell. of Gas troenterology.