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

Plain Language Summary

Simplified for easier understanding

This study is comparing standard versus extended courses of preventive antibiotics after a complex abdominal surgery called pancreatoduodenectomy (Whipple procedure). The goal is to determine whether a longer course of antibiotics reduces the risk of infection after this surgery, which carries a high risk of bile contamination. **You may be eligible if:** - You are over 18 years old - You are scheduled for a planned (elective) pancreatoduodenectomy - You have either had prior bile drainage (a drain placed in the bile duct before surgery) or have a tumor affecting the ampulla (the junction where the bile duct meets the intestine), which places you at higher risk for bacterial contamination during surgery **You may NOT be eligible if:** - You are pregnant - You have an allergy or intolerance to the study antibiotics - You are already on therapeutic antibiotics for an active infection (such as cholangitis or liver abscesses) - Your kidney function is significantly reduced (eGFR below 60) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT05784311


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