Overview

Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)

Status:
Not yet recruiting
Trial end date:
2026-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Leiden University Medical Center
Treatments:
Cefuroxime
Cefuroxime axetil
Metronidazole
Criteria
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)