Dual-center randomized clinical trial exploring the optimal duration of antimicrobial prophylaxis in patients undergoing pancreaticoduodenectomy following biliary drainage

Objectives: 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. Conclusion: Single-day prophylactic use of CZOP is appropriate for patients who undergo PD following PBD without preoperative cholangitis.