Effect of antibiotic prophylaxis on acute necrotizing pancreatitis: Results of a randomized controlled trial

Background and Aims: This study addresses whether antibiotic prophylaxis is beneficial for acute necrotizing pancreatitis. Methods: This randomized, controlled trial enrolled 276 patients with severe acute pancreatitis. There were 56 patients with 30% or more necrosis proved by contrast‐enhanced computerized tomography who were eligible for randomization: 29 in the study group and 27 in the control group, who received i.v. imipenem–cilastatin (3 × 500 mg/day) within 72 h of the onset of symptoms for 7–14 days, and no antibiotic prophylaxis, respectively. The primary end‐point was the incidence of infectious complication. The secondary end‐points were mortality, the incidence of necrosectomy for infected necrosis, the incidence of organ complication and hospital courses. Results: Characteristics of baseline data were similar in the two groups. No significant differences were found in the incidence of infected pancreatic necrosis (37% vs 27.6%), mortality (10.3% vs 14.8%) and the incidence of operative necrosectomy (29.6% vs 34.6%) between the study group and the control group (P > 0.05). The incidence of extrapancreatic infections, organ complications and hospital courses between the groups were also not significantly different. However, a significantly increased incidence of fungal infection was observed in the study group versus the control group (36.1% vs 14.2%, P