RecruitingPhase 4NCT05784311

Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)

Standard Versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes After Whipple's Procedure (SPARROW): a Multicenter, Randomized Controlled Trial


Sponsor

Leiden University Medical Center

Enrollment

344 participants

Start Date

Mar 6, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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

Interventions

DRUGCefuroxime

1500mg IV cefuroxime thrice daily during five days.

DRUGMetronidazole

500mg IV metronidazole thrice daily during five days.


Locations(11)

Leiden University Medical Center

Leiden, South Holland, Netherlands

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05784311


Related Trials