Comparing standard and prolonged antibiotic use after pancreas surgery
Standard Versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes After Whipple's Procedure (SPARROW): a Multicenter, Randomized Controlled Trial
This study is testing if giving patients longer antibiotics after pancreas surgery can help prevent infections and improve recovery compared to the standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 344 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 11 sites (Leiden, South Holland and 10 other locations) |
| Trial ID | NCT05784311 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to evaluate the effectiveness of prolonged antibiotic prophylaxis in preventing organ/space surgical site infections (OSIs) in patients undergoing pancreatoduodenectomy who are at high risk for contaminated bile. Participants will be randomly assigned to receive either standard or extended antibiotic treatment for five days post-surgery. The study will also assess other postoperative outcomes, including major morbidity and length of hospital stay, while analyzing the concordance of bile cultures with postoperative infections. The trial seeks to clarify the role of pre-emptive antibiotics in this surgical context, where current guidelines are inconsistent.
Who should consider this trial
Good fit: Ideal candidates are adult patients over 18 years old undergoing elective pancreatoduodenectomy with a high risk for contaminated bile.
Not a fit: Patients with contraindications to the study antibiotics or those requiring preoperative antibiotic treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced infection rates for patients undergoing pancreatoduodenectomy.
How similar studies have performed: Previous studies have shown conflicting results regarding the effectiveness of antibiotic prophylaxis in similar surgical contexts, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leiden, South Holland and 10 other locations
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands (Not_yet_recruiting)
- Amsterdam University Medical Center — Amsterdam, Netherlands (Recruiting)
- Amphia Ziekenhuis — Breda, Netherlands (Recruiting)
- Catharina Ziekenhuis — Eindhoven, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
- Groningen University Medical Center — Groningen, Netherlands (Recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Recruiting)
- Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
- Erasmus MC Cancer Institute — Rotterdam, Netherlands (Recruiting)
- Regional Academic Cancer Center Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: J. Sven D. Mieog, MD PhD — Leiden University Medical Center
- Study coordinator: Daphne HM Droogh, MD
- Email: d.h.m.droogh@lumc.nl
- Phone: 071 5261334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.