(SPARROW) Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple’s procedure (SPARROW): a multicenter, randomized controlled trial
Phase 1
- Conditions
- Pancreatoduodenectomy with a high risk for contaminated bileTherapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2024-510766-16-00
- Lead Sponsor
- Academisch Ziekenhuis Leiden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 344
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method