目的:这项双中心随机对照试验的目的是确定接受胰十二指肠切除术(PD)术前胆道引流(PBD)但无胆管炎的患者抗菌药物预防的最佳持续时间。
背景:一些报道表明,接受胰腺切除术的患者的PBD增加了围手术期并发症的发生率。然而,目前尚无临床试验以PBD后接受PD的患者为研究对象,评估抗菌药物预防的最佳持续时间.
方法:将2012年3月至2016年12月期间接受PD的82例患者随机分配到1天组(n=40),其中头孢唑兰(CZOP)作为抗菌药物预防仅在手术当天给予,或5天组(n=42),从手术当天开始连续5天给予CZOP。我们评估了PD后感染和其他并发症的发生率。
结果:在总体感染并发症的发生率方面,1天组的预后明显优于5天组(P<0.05)(15%vs36%,分别),腹内脓肿(3%vs21%,分别),临床相关的术后胰瘘(8%vs24%,分别),和Clavien-DindoIII-V级并发症(10%vs31%,分别)。术后住院时间在1天组显著缩短(10天比15天,P=0.018)。仅在5天组的患者中,从引流液中分离出厌氧菌和耐甲氧西林球菌。
结论:单日预防性使用CZOP适合于在PBD后接受PD而没有术前胆管炎的患者。
OBJECTIVE: The aim of this dual-center randomized controlled trial was to determine the optimal duration of antimicrobial prophylaxis in patients treated with pancreaticoduodenectomy (PD) who underwent preoperative biliary drainage (PBD) but were without cholangitis.
BACKGROUND: Some reports showed that PBD in patients undergoing pancreatectomy increased the rate of perioperative complications. However, no clinical trial has evaluated the optimal duration of antimicrobial prophylaxis with a focus on patients who underwent PD following PBD.
METHODS: A total of 82 patients who underwent PD between March 2012 and December 2016 were randomly assigned to either a 1-day group (n = 40), in which
cefozopran (CZOP) as antimicrobial prophylaxis was given only on the day of surgery, or a 5-day group (n = 42), in which CZOP was given for 5 consecutive days beginning on the day of surgery. We evaluated the incidence of infectious and other complications after PD.
RESULTS: Outcomes were significantly better in the 1-day group compared with the 5-day group (P < 0.05) in terms of the incidence of overall infectious complications (15% vs 36%, respectively), intra-abdominal abscess (3% vs 21%, respectively), clinically relevant postoperative pancreatic fistula (8% vs 24%, respectively), and Clavien-Dindo grade III-V complications (10% vs 31%, respectively). Duration of postoperative hospital stay was significantly shorter in the 1-day group (10 days vs 15 days, P = 0.018). Anaerobic bacteria and methicillin-resistant cocci were isolated from the drainage fluid only among patients in the 5-day group.
CONCLUSIONS: Single-day prophylactic use of CZOP is appropriate for patients who undergo PD following PBD without preoperative cholangitis.