Evidence map›Paper›PMID 40083036›Full record

ArticleTrials2025

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, M G J de Boer, J van Prehn, H Putter, B A Bonsing, K Bosscha, S A W Bouwense, J P B M Braak, F J H Hoogwater, D J Lips and 9 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

D H M DrooghDepartment of Surgery, Leiden University Medical Centre, Leiden, the Netherlands. D.H.M.Droogh@LUMC.nl.
M G J de BoerDepartments of Infectious Diseases, Leiden University Medical Centre for Infectious Diseases (LU-CID), Leiden, the Netherlands.
J van PrehnDepartment of Medical Microbiology and Infection Control, Leiden University Medical Centre for Infectious Diseases (LU-CID), Leiden, the Netherlands.
H PutterDepartment of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, the Netherlands.
B A BonsingDepartment of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
K BosschaDepartment of Surgery, Jeroen Bosch Ziekenhuis, Den Bosch, the Netherlands.
S A W BouwenseDepartment of Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands.
J P B M BraakDepartment of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
F J H HoogwaterDepartment of Surgery, University Medical Centre Groningen, Groningen, the Netherlands.
D J LipsDepartment of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands.
M D P LuyerDepartment of Surgery, Catharina Ziekenhuis, Eindhoven, the Netherlands.
M W J StommelDepartment of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.
J H WijsmanDepartment of Surgery, Amphia Ziekenhuis, Breda, the Netherlands.
M G BesselinkAmsterdam UMC, Department of Surgery, Location University of Amsterdam, Amsterdam, the Netherlands.
H C van SantvoortDepartment of Surgery, Regional Academic Cancer Centre Utrecht (RAKU), Utrecht, the Netherlands.
B Groot KoerkampDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
A L VahrmeijerDepartment of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
J S D MieogDepartment of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
Dutch Pancreatic Cancer Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConsensus 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.

methodsThe 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 registrationClinicalTrials.gov NCT0578431. Registered on March 23, 2023.

Indexed as

Anti-Bacterial AgentsAntibiotic ProphylaxisPancreaticoduodenectomySurgical Wound InfectionCefazolinGentamicinsHumansMetronidazoleMulticenter Studies as TopicNetherlandsRandomized Controlled Trials as TopicTreatment OutcomeAnti-Bacterial AgentsCefazolinGentamicinsMetronidazoleAmpullary carcinomaAntibiotic prophylaxisAntimicrobial policyBiliary drainageContaminated bileExtended antibiotic prophylaxisIntraoperative obtained bile culturesPancreatic ductal adenocarcinomaPancreatoduodenectomyPre-emptive antibiotic treatmentWhipple

Identifiers

PMID40083036
PMCPMC11908089

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.