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 anti-inflammatory cytokine with immunosuppressive and anti-inflammatory 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 for the prevention of ERCP-induced pancreatitis. METHODS: Patients were randomized to receive a single i.v. dose of recombinant human IL-10 (8 μg/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 ≥2 days. Severity of pancreatitis was based on days of hospitalization. RESULTS: Two hundred patients were enrolled (101 IL-10, 99 placebo). No difference in age, gender, degree of pancreatic duct filling, therapeutic intervention, or complication was detected between the two groups. Eleven patients in the IL-10 group and nine patients in the placebo group had pancreatitis (p = 0.65). The median length of hospitalization was 4 days in the IL-10 group and 3 days in the placebo group (p = 0.75). CONCLUSIONS: IL-10 at the 8-/μg/kg i.v. dose was not effective in reducing the incidence or severity of ERCP-induced pancreatitis. Further investigations are necessary to determine if manipulation of the cytokine pathway can prevent ERCP-induced pancreatitis.