Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)
Recruiting
Phase 4
Interventional Study
Pancreatic Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 90
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 344 (estimated)
- Sponsor
- Leiden University Medical Center · Other
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About This Trial
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 clinicall…
Trial Locations
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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. al…
Contacts