Hope or hype—cytokine therapy in ERCP-induced pancreatitis

Abstract

In a single-center study from Belgium, Deviere et al. reported the use of the anti-inflammatory cytokine interleukin (IL) 10 as prophylaxis against ERCP-induced pancreatitis. One hundred forty-four patients undergoing ERCP were randomized to receive either a placebo (group 0) or a single i.v. injection of 4 μg/kg (group 1) or 20 μg/kg (group 2) of IL-10 in a double-blinded manner. Seven patients were excluded on an intention to treat or per protocol basis. The primary endpoint of the study was the effect of IL-10 on serum hydrolases (amylase and lipase) measured at 4, 24, and 48 h after ERCP. Hyperhydrolasemia was defined as an increase in amylase and/or lipase levels more than three times normal values. The secondary endpoint was to evaluate changes in plasma cytokines (IL-6, IL-8, and tumor necrosis [TNF] serum levels) and the incidence of clinical acute pancreatitis. This was defined as hyperhydrolasemia associated with new or worsened abdominal pain persisting for more than 4 h after ERCP. The three groups were comparable for number of patients (groups 0, 1, and 2 consisted of 45, 48, and 44 patients, respectively) as well as for age, sex, underlying disease, indication for treatment, and baseline plasma levels of C-reactive protein, cytokines, and hydrolases. The authors found no significant difference in serum C-reactive protein, cytokine, and hydrolase plasma levels between the groups after ERCP. Overall, 43 of the 137 study patients developed hyperhydrolasemia. These were distributed as follows: 18 (40%) in group 0, 14 (29%) in group 1, and 11 (25%) in group 2 ( p = 0.297, nonsignificant). Overall, 19 patients (of the entire study population) developed acute clinical pancreatitis and were distributed as follows: 11 (24.4%) in group 0, five (10.4%) in group 1, and three (6.8%) in group 2 ( p = 0.038). Two severe cases were observed in the placebo group. Logistic regression identified three independent risk factors for post-ERCP pancreatitis: IL-10 administration (odds ratio [OR] = 0.46, 95% CI = 0.22–0.96, p = 0.039), pancreatic sphincterotomy (OR = 5.04, 95% CI = 1.53–16.61, p = 0.008), and acinarization (OR = 8.19, 95% CI = 1.83–36.57, p = 0.006). The authors conclude that a single i.v. dose of IL-10 30 min before the procedure independently reduces the frequency of post-ERCP pancreatitis.