Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)
Recruiting · NCT05784311 · Interventional (participants receive a specific treatment) · Lead sponsor: Leiden University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
11 locations listed.
- Jeroen Bosch Ziekenhuis - 's-Hertogenbosch, Netherlands
- Amsterdam University Medical Center - Amsterdam, Netherlands
- Amphia Ziekenhuis - Breda, Netherlands
- Catharina Ziekenhuis - Eindhoven, Netherlands
- Medisch Spectrum Twente - Enschede, Netherlands
- Groningen University Medical Center - Groningen, Netherlands
- Maastricht University Medical Center - Maastricht, Netherlands
- Radboud University Medical Center - Nijmegen, Netherlands
- Erasmus MC Cancer Institute - Rotterdam, Netherlands
- Regional Academic Cancer Center Utrecht - Utrecht, Netherlands
- Leiden University Medical Center - Leiden, South Holland, Netherlands