A randomized, double blind study of interleukin 10 for the prevention of ERCP-induced pancreatitis

OBJECTIVES: Inflammatory cytokines are released during acute pancreatitis. Interleukin 10 (IL-10) is a potent antiinflammatory cytokine with immunosup pressive and antiinflammatory activities. IL-10 has been shown to attenuate pancreatitis in an animal model. A double blind, placebo-controlled pilot study was conducted to evaluate the safety and efficacy of low dose IL-10 f or the prevention of ERCP-induced pancreatitis. METHODS: Patients were randomized to receive a single i.v. dose of recombin ant human IL-10 (8 mug/kg) or a placebo i.v. bolus injection 15 min before the procedure. Pancreatitis was defined as abdominal pain radiating to the back associated with elevated amylase or lipase two or more times the upper limit of normal requiring hospitalization for greater than or equal to2 da ys. Severity of pancreatitis was based on days of hospitalization. RESULTS: Two hundred patients were enrolled (101 IL-10, 99 placebo). No dif ference in age, gender, degree of pan creatic duct filling, therapeutic int ervention, or complication was detected between the two groups. Eleven pati ents in the IL-IO group and nine patients in the placebo group had pancreat itis (p = 0.65). The median length of hospitalization was 4 days in the TL- IO group and 3 days in the placebo group (p = 0.75). CONCLUSIONS: IL-10 at the 8-mug/kg i.v. dose was not effective in reducing the incidence or severity of ERCP-induced pancreatitis. Further investigati ons are necessary to determine if manipulation of the cytokine pathway can prevent ERCP-induced pancreatitis.