NCT05784311 Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)
| NCT ID | NCT05784311 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Leiden University Medical Center |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 344 participants |
| Start Date | 2023-03-06 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 344 participants in total. It began in 2023-03-06 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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) * A reduced renal function, defined as an eGFR of \<60 ml/min/1.73m2 measured on the closest timepoint prior to pancreatoduodenectomy
Contact & Investigator
J. Sven D. Mieog, MD PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT05784311 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05784311 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05784311 currently recruiting?
Yes, NCT05784311 is actively recruiting participants. Contact the research team at d.h.m.droogh@lumc.nl for enrollment information.
Where is the NCT05784311 trial being conducted?
This trial is being conducted at Leiden, Netherlands, 's-Hertogenbosch, Netherlands, Amsterdam, Netherlands, Breda, Netherlands and 7 additional locations.
Who is sponsoring the NCT05784311 clinical trial?
NCT05784311 is sponsored by Leiden University Medical Center. The principal investigator is J. Sven D. Mieog, MD PhD at Leiden University Medical Center. The trial plans to enroll 344 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.