Pretreatment With Methylprednisolone to Prevent Ercp-Induced Pancreatitis: A Randomized, Multicenter, Placebo-Controlled Clinical Trial
Abstract
Objective:Pancreatitis remains the major complication of endoscopic retrograde cholangiopancreatography (ERCP). Uncontrolled data suggest a lower incidence of pancreatitis in patients with a history of iodine sensitivity when given pretreatment with ...
Objective:Pancreatitis remains the major complication of endoscopic retrograde 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 corticosteroid, 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 were excluded for technical reasons at the time of ERCP. Overall, the incidence of pancreatitis was 16 of 129 (12.4%, 95% CI: 6.7–18.1%) in the 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 methylprednisolone group compared to the control group (31.8%vs 16.8%, p= 0.005), the incidence of pancreatitis was not different when patients undergoing sphincterotomy were analyzed separately (13.6% in the methylprednisolone group and 9.6% in the placebo group, p= 0.50). There 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.