Division of Research and Optimal Patient Care, American College of Surgeons, Chicago, IL, USA.
Department of Surgery, Northwestern Medicine, Northwestern Quality Improvement, Research, and Education in Surgery (NQUIRES), Chicago, IL, USA.
Cancer Treat Res. 2024;192:131-145. doi: 10.1007/978-3-031-61238-1_7.
Surgical site infection is a common complication following pancreaticoduodenectomy and is a major source of postoperative morbidity. Surgical site infection is more common among patients who undergo preoperative biliary instrumentation, likely because of the introduction of intestinal flora into the normally sterile biliary tree. Frequently, bacterial isolates from surgical site infections after pancreaticoduodenectomy demonstrate resistance to the antibiotic agents typically used for surgical prophylaxis, suggesting that broad-spectrum coverage may be beneficial. This chapter summarizes the current evidence regarding surgical site infection following pancreatic surgery and describes the rationale and methodology underlying a multicenter randomized trial evaluating piperacillin-tazobactam compared with cefoxitin for surgical site infection prevention following pancreaticoduodenectomy. As the first U.S. randomized surgical trial to utilize a clinical registry for data collection, this study serves as proof of concept for registry-based clinical trials. The trial has successfully completed patient accrual, and study results are forthcoming.
术后手术部位感染是胰十二指肠切除术的常见并发症，也是术后发病率的主要来源。术前胆道器械检查的患者更容易发生手术部位感染，这可能是因为肠道菌群被引入了通常无菌的胆道树。通常，胰十二指肠切除术后手术部位感染的细菌分离株对用于手术预防的抗生素药物表现出耐药性，这表明广谱覆盖可能是有益的。本章总结了关于胰腺手术后手术部位感染的现有证据，并描述了一项多中心随机试验的原理和方法，该试验评估了哌拉西林-他唑巴坦与头孢西丁预防胰十二指肠切除术后手术部位感染的效果。作为首个利用临床注册中心进行数据收集的美国随机外科试验，该研究为基于注册中心的临床试验提供了概念验证。该试验已成功完成患者入组，研究结果即将公布。
