CTIS2024-510766-16-00
Active, not recruiting
Phase 1
(SPARROW) Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple’s procedure (SPARROW): a multicenter, randomized controlled trial - NL82304.058.22
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pancreatoduodenectomy with a high risk for contaminated bile
- Sponsor
- Academisch Ziekenhuis Leiden
- Enrollment
- 344
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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), Indication for endocarditis prophylaxis, Preoperative planned therapeutic antibiotic treatment after surgery (i.e. for cholangitis or liver abscesses), A reduced renal function, defined as a eGFR of \<60 ml/min/1\.73m2 and measured on a the closest timepoint prior to pancreatoduodenectomy
Outcomes
Primary Outcomes
Not specified
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