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. 2025 Mar 13;26(1):88.
doi: 10.1186/s13063-024-08574-z.

Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple resection (SPARROW): a study protocol for a multicentre, open-label, randomised controlled trial

D H M Droogh  1 , M G J de Boer  2   3 , J van Prehn  4 , H Putter  5 , B A Bonsing  6 , K Bosscha  7 , S A W Bouwense  8 , J P B M Braak  6 , F J H Hoogwater  9 , D J Lips  10 , M D P Luyer  11 , M W J Stommel  12 , J H Wijsman  13 , M G Besselink  14   15 , H C van Santvoort  16 , B Groot Koerkamp  17 , A L Vahrmeijer  6 , J S D Mieog  6 ; Dutch Pancreatic Cancer Group
Affiliations

Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple resection (SPARROW): a study protocol for a multicentre, open-label, randomised controlled trial

D H M Droogh et al. Trials. .

Abstract

Background: Consensus and evidence on the impact of pre-emptive antibiotic treatment after pancreatoduodenectomy is lacking, which is reflected by contradictory recommendations in (inter)national guidelines and current clinical practice. Pre-emptive antibiotic treatment may reduce the risk of abdominal surgical site infections in patients with a high risk of contaminated bile undergoing pancreatoduodenectomy. This pertains mostly patients with preoperative biliary drainage or an ampullary malignancy. The SPARROW trial will evaluate the effect of pre-emptive antibiotic treatment in patients with preoperative biliary drainage or an ampullary malignancy undergoing pancreatoduodenectomy.

Methods: The SPARROW trial is a multicentre, open-label, randomised controlled trial evaluating the effect of pre-emptive antibiotic treatment in patients with a high risk of contaminated bile undergoing pancreatoduodenectomy. A total of 366 evaluable patients will be included in twelve centres in the Netherlands. Patients will be randomly allocated to either the perioperative antibiotic prophylaxis and pre-emptive antibiotic treatment (intervention) arm and the perioperative antibiotic prophylaxis (control) arm. In both study arms, the perioperative antibiotic prophylaxis consists of cefazolin, metronidazole and a single-dose of gentamicin, which is discontinued after surgery. In the pre-emptive antibiotic treatment arm, an additional antibiotic course of 5 days of cefuroxime and metronidazole is started postoperatively. The primary outcome is a clinically relevant organ/space surgical site infection (OSI) up to 90 days after surgery. Secondary outcomes include other clinically relevant complications (such as isolated OSI, superficial incisional surgical site infections, postoperative pancreatic fistula, ICU admission, readmission, and in-hospital and 90-day mortality), use of therapeutic antibiotics, and concordance between perioperative obtained bile cultures and cultures obtained from infectious complications.

Discussion: The SPARROW trial will provide evidence on the effect of pre-emptive antibiotic treatment in patients with a high risk of contaminated bile undergoing pancreatoduodenectomy to provide recommendations for an improved and standardised antimicrobial policy.

Trial registration: ClinicalTrials.gov NCT0578431. Registered on March 23, 2023.

Keywords: Ampullary carcinoma; Antibiotic prophylaxis; Antimicrobial policy; Biliary drainage; Contaminated bile; Extended antibiotic prophylaxis; Intraoperative obtained bile cultures; Pancreatic ductal adenocarcinoma; Pancreatoduodenectomy; Pre-emptive antibiotic treatment; Whipple.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Ethical approval for the SPARROW trial was received by the medical ethical review committee Leiden Den Haag Delft (METC LDD, identification number NL82304.058.22). Patients are only able to participate in the SPARROW trial after providing written informed consent. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Pre-emptive antibiotic treatment after pancreaticoduodenectomy in 15 Dutch pancreatic surgery centres. The use of pre-emptive treatment for pancreatoduodenectomy in the Netherlands. A Use of only perioperative antibiotic prophylaxis versus pre-emptive antibiotic treatment in centres and the indication for pre-emptive antibiotic treatment. B Type of antibiotic agent used as pre-emptive antibiotic treatment. C Duration of pre-emptive antibiotic treatment
See this image and copyright information in PMC

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