Actively Recruiting

Phase 4
Age: 18Years - 90Years
All Genders
NCT05784311

Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)

Led by Leiden University Medical Center · Updated on 2024-10-21

344

Participants Needed

11

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Contraindication for the study antibiotics (e.g. allergy or intolerance)
  • Preoperative planned therapeutic antibiotic treatment (i.e. for cholangitis or liver abscesses)
  • Reduced renal function defined as an eGFR of <60 ml/min/1.73m2 measured before surgery

AI-Screening

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Trial Site Locations

Total: 11 locations

1

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333 ZA

Actively Recruiting

2

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Not Yet Recruiting

3

Amsterdam University Medical Center

Amsterdam, Netherlands

Actively Recruiting

4

Amphia Ziekenhuis

Breda, Netherlands

Actively Recruiting

5

Catharina Ziekenhuis

Eindhoven, Netherlands

Actively Recruiting

6

Medisch Spectrum Twente

Enschede, Netherlands

Actively Recruiting

7

Groningen University Medical Center

Groningen, Netherlands

Actively Recruiting

8

Maastricht University Medical Center

Maastricht, Netherlands

Actively Recruiting

9

Radboud University Medical Center

Nijmegen, Netherlands

Actively Recruiting

10

Erasmus MC Cancer Institute

Rotterdam, Netherlands

Actively Recruiting

11

Regional Academic Cancer Center Utrecht

Utrecht, Netherlands

Actively Recruiting

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Research Team

D

Daphne HM Droogh, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW) | DecenTrialz