Droogh D H M, de Boer M G J, van Prehn J, Putter H, Bonsing B A, Bosscha K, Bouwense S A W, Braak J P B M, Hoogwater F J H, Lips D J, Luyer M D P, Stommel M W J, Wijsman J H, Besselink M G, van Santvoort H C, Koerkamp B Groot, Vahrmeijer A L, Mieog J S D
Department of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
Departments of Infectious Diseases, Leiden University Medical Centre for Infectious Diseases (LU-CID), Leiden, the Netherlands.
Trials. 2025 Mar 13;26(1):88. doi: 10.1186/s13063-024-08574-z.
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.
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.
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.
ClinicalTrials.gov NCT0578431. Registered on March 23, 2023.
胰十二指肠切除术后预防性抗生素治疗的影响缺乏共识和证据，这在（国际）指南和当前临床实践中的矛盾建议中有所体现。预防性抗生素治疗可能会降低接受胰十二指肠切除术且胆汁污染风险高的患者腹部手术部位感染的风险。这主要适用于术前进行胆汁引流或患有壶腹恶性肿瘤的患者。SPARROW试验将评估预防性抗生素治疗对接受胰十二指肠切除术且术前进行胆汁引流或患有壶腹恶性肿瘤的患者的效果。
SPARROW试验是一项多中心、开放标签、随机对照试验，评估预防性抗生素治疗对接受胰十二指肠切除术且胆汁污染风险高的患者的效果。荷兰的12个中心将总共纳入366例可评估患者。患者将被随机分配到围手术期抗生素预防和预防性抗生素治疗（干预）组以及围手术期抗生素预防（对照）组。在两个研究组中，围手术期抗生素预防均包括头孢唑林、甲硝唑和单剂量庆大霉素，术后停用。在预防性抗生素治疗组中，术后开始额外一个疗程为期5天的头孢呋辛和甲硝唑治疗。主要结局是术后90天内临床相关的器官/腔隙手术部位感染（OSI）。次要结局包括其他临床相关并发症（如孤立性OSI、浅表切口手术部位感染、术后胰瘘、入住重症监护病房、再次入院以及住院期间和90天死亡率）、治疗性抗生素的使用以及围手术期获得的胆汁培养结果与感染性并发症获得的培养结果之间的一致性。
SPARROW试验将为接受胰十二指肠切除术且胆汁污染风险高的患者预防性抗生素治疗的效果提供证据，以便为改进和标准化抗菌策略提供建议。
ClinicalTrials.gov NCT0578431。于2023年3月23日注册。
