Kursenko, R. V., Trushin, A. A., Vervekin, I. V., Kupenskaya, T. V., Ten, O. A., Zaharenko, A. A., & Udoratin, O. A. (2024). Personalised Surgical Site Infection Prophylaxis Based on Bile Cultures in Patients Undergoing Pancreaticoduodenectomy: A Clinical Trial Protocol. Voprosy Onkologii, 70(5), 878–886. https://doi.org/10.37469/0507-3758-2024-70-5-878-886

Abstract

Introduction. There is a high rate of surgical site infections (SSI) following pancreaticoduodenectomy (PDE). Bile microbial contamination is bacteriobilia resulting from preoperative biliary drainage (PBD). It has a high incidence in this cohort of patients. Despite the multifactorial nature of the causes influencing the development of surgical site infections (SSI) after PDE, bacteriobilia appears to be one of the most significant factors in the development of SSI. Intraoperative bile microbial and SSI microbial cultures are dominated by pathogens resistant to standard perioperative antibiotic prophylaxis. In order to reduce the incidence of SSI after PBD, further research into methods of influencing bacteriobilia, including an alternative approach to antibiotic prophylaxis, is required.

Materials and Methods. A single-centre comparative cohort trial with retrospective and prospective cohorts is planned. Groups of patients with periampullary tumors who underwent preoperative biliary drainage followed by PDE will be studied. In both groups the bacterial culture of the bile from the biliary drainage will be analyzed. The retrospective control group will receive standard perioperative antibiotic prophylaxis (PAP), while the prospective study group will receive personalized PAP based on pre-PDE bile culture data. In both groups, the primary endpoint will be the incidence of SSI following PDE. The expected rate of post-operative infectious complications is 15 % in the main group and 40 % in the control group. If the probability of first-order error (α) = 0.05, second-order error (β) = 0.2, the power of the study is (1-β) = 0.8. Based on the calculation using Lehr's formula, the volume of each group should be at least n = 49.

Conclusion. Based on the results of the trial, the need for personalised PAP in patients with PBD scheduled for periampullary PDE will be assessed.

https://doi.org/10.37469/0507-3758-2024-70-5-878-886

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