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

Abstract

ObjectivesThe 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.BackgroundSome 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.MethodsA 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.ResultsOutcomes 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.ConclusionSingle‐day prophylactic use of CZOP is appropriate for patients who undergo PD following PBD without preoperative cholangitis.

Clinical implications of bile cultures obtained during pancreatoduodenectomy: a cohort study and meta-analysis

“…postoperative antibiotic prophylaxis in only patients with preoperative biliary drainage and reported no benefit of prolonged postoperative prophylaxis regarding infectious complications in this group of patients. 46 However, the overall effect of standard prolonged antibiotic prophylaxis after pancreatoduodenectomy remains undetermined. As a more personalized alternative, several retrospective and one randomized controlled trial investigated the value of postoperative antibiotic prophylaxis based on IOBCs or even on preoperative cultures.…”

Study protocol of REpeat versus SIngle ShoT Antibiotic prophylaxis in major Abdominal Surgery (RESISTAAS I): a prospective observational study of antibiotic prophylaxis practice for patients undergoing major abdominal surgery

“…Surgery has been made significantly safer through perioperative antibiotic prophylaxis, reducing SSI 27. However, studies on postoperative antibiotic prophylaxis have underlined the need to abandon certain dogmatic practices of prescribing antibiotics out of precaution 7 8. Studies show that even if the surgical site is contaminated through intestinal perforations, prolonged use of antibiotics does not bring any advantages 7 28.…”

“… 6 7 Additionally, postoperative continuation of antibiotic prophylaxis is associated with a multitude of non-infectious complications. 8 Most analysis on perioperative antibiotic prophylaxis investigate patients after elective orthopaedic interventions—procedures that fundamentally differ in the degree of contamination and hygiene regulations in comparison to visceral surgical operations. Only few studies analyse the association between antibiotic prophylaxis and duration of surgery without differentiation between abdominal, traumatological, gynaecological or cardiovascular procedures.…”

“…Continuation of antibiotics after surgical procedures shows no advantages and is associated with an increase in wound infections 6 7. Additionally, postoperative continuation of antibiotic prophylaxis is associated with a multitude of non-infectious complications 8. Most analysis on perioperative antibiotic prophylaxis investigate patients after elective orthopaedic interventions—procedures that fundamentally differ in the degree of contamination and hygiene regulations in comparison to visceral surgical operations.…”

Validation of the triple‐checked criteria for drain management after pancreatectomy

“…Regardless of the surgical procedure, a prophylactic antimicrobial agent was used on the day of surgery in patients without cholangitis, and until POD 5 in patients with cholangitis. 10 Somatostatin analogs were not used in any of the patients.…”