Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)

Summary

The goal of this multicenter randomized controlled trial is to evaluate the additional value of pre-emptive antibiotic treatment on clinically relevant organ/space surgical site infections (OSIs) in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile. The main objectives it aims to answer are: * To evaluate the effect of pre-emptive antibiotic prophylaxis on clinically relevant OSIs in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile * To evaluate the effect of pre-emptive antibiotic prophylaxis on other postoperative outcomes (e.g. OSIs, superficial SSIs, POPF, PPH, major morbidity, ICU admission, readmission, length of hospital stay, and mortality). * To evaluate concordance between perioperatively obtained bile cultures and postoperative cultures from infectious sites, and to evaluate antibiotic sensitivity patterns of the cultured microorganisms. Participants will be randomized with a 1:1 allocation before surgery into the intervention or control group: * Patients in the intervention group will receive perioperative prophylaxis (similar to the control group) followed by five days of 1500mg IV cefuroxime and 500mg IV metronidazole thrice daily. * Patients in the control group will only receive perioperative prophylaxis (a single dose of 5-7mg/kg gentamicin followed by 2gr IV cefazolin and 500mg IV metronidazole every 4h of surgery), which will be discontinued after surgery.

Interventions

• Cefuroxime · DRUG

  1500mg IV cefuroxime thrice daily during five days.

• Metronidazole · DRUG

  500mg IV metronidazole thrice daily during five days.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Patients undergoing elective pancreatoduodenectomy with a high risk for contaminated bile defined as patients with preoperative biliary drainage or an ampullary malignancy.
* Age \>18 years

Exclusion Criteria:

* Pregnancy
* Contraindication for the study antibiotics (e.g. allergy or intolerance)
* Preoperative planned therapeutic antibiotic treatment (i.e. for cholangitis or liver abscesses)
* A reduced renal function, defined as an eGFR of \<60 ml/min/1.73m2 measured on the closest timepoint prior to pancreatoduodenectomy

Sites (11)

• Leiden University Medical Center, Leiden, South Holland, Netherlands · RECRUITING
• Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands · NOT_YET_RECRUITING
• Amsterdam University Medical Center, Amsterdam, Netherlands · RECRUITING
• Amphia Ziekenhuis, Breda, Netherlands · RECRUITING
• Catharina Ziekenhuis, Eindhoven, Netherlands · RECRUITING
• Medisch Spectrum Twente, Enschede, Netherlands · RECRUITING
• Groningen University Medical Center, Groningen, Netherlands · RECRUITING
• Maastricht University Medical Center, Maastricht, Netherlands · RECRUITING
• Radboud University Medical Center, Nijmegen, Netherlands · RECRUITING
• Erasmus MC Cancer Institute, Rotterdam, Netherlands · RECRUITING
• Regional Academic Cancer Center Utrecht, Utrecht, Netherlands · RECRUITING