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Introduction: Pancreaticoduodenectomy (PD) remains a complex surgical procedure with infectious complications affecting nearly 50% of patients. Patients who undergo biliary drainage with stent placement prior to neoadjuvant treatment (NAT) reportedly have higher infection rates following PD. The aim of the current study is to evaluate the differences in postoperative infectious complication rates based on the duration of post operative prophylactic antibiotics in patients with indwelling metal biliary stent who had NAT., Methods: A retrospective institutional pancreatic cancer database was queried for patients who had a metal biliary stent placed prior to NAT initiation, followed by subsequent PD between 2014 and 2021. Duration of postoperative prophylactic antibiotics was defined as short (SC: ≤ 24 h) or extended (EC: > 24 h-7 days). The primary outcome of interest was surgical site infection (SSI)., Results: Two hundred and ninety-five (n = 295) patients were identified of which the majority (n = 205, 69.5%) received a short course of antibiotics postoperatively. Baseline characteristics were similar between the two cohorts including age, sex, BMI, and comorbidity index. EC patients received more NAT cycles (4 vs. 3, p < 0.001) and underwent an open PD more frequently (61.8% vs. 41.0%, p < 0.001). SSI occurred in 64 (21.7%) patients; SC cohort: 54, 26.3% vs. EC cohort:10, 11.1%, (p = 0.003). Additionally, the SC cohort demonstrated a higher incidence of major complications (Clavien-Dindo ≥ 3: 51 [24.9%] vs. 13 [14.4%], p = 0.045). On the logistic regression model examining factors associated with SSI, higher BMI (continuous variable) was associated with increased odds of SSI (OR: 1.05 [95%CI: 1.00, 1.10, p = 0.040), while EC was protective (OR: 0.36 [95%CI: 0.17, 0.75], p = 0.007)., Conclusions: These data suggest that an extended course of perioperative antibiotic correlates with reductions in SSI and major morbidity following PD in patients with a metallic biliary stent placed prior to NAT course. These results require validation in a future randomized clinical trial examining a larger cohort of patients with further emphasis on the types of perioperative antibiotics administered., (© 2023. The Society for Surgery of the Alimentary Tract.)

Background: Hepatopancreaticobiliary (HPB) diseases carry high morbidity despite efforts aimed at their reduction. An assessment of their trial characteristics is paramount to determine trial design adequacy and highlight areas for improvement. As such, the aim of this study is to assess HPB surgery trial characteristics, summarize logistic, financial, and practical reasons behind early discontinuation, and propose potential interventions to prevent this in the future., Methods: All clinical trials investigating HPB surgery registered on ClinicalTrials.gov from October 1st, 2007 (inclusive), to April 20th, 2021 (inclusive), were examined. Trial characteristics were collected including, but not limited to, study phase, duration, patient enrollment size, location, and study design. Peer-reviewed publications associated with the selected trials were also assessed to determine outcome reporting., Results: A total of 1776 clinical trials conducted in 43 countries were identified, the majority of which were conducted in the USA. Of these trials, 32% were reported as "completed" whereas 12% were "discontinued." The most common cause of trial discontinuation was low accrual, which was reported in 37% of terminated studies. These resulted in 413 published studies. Most trials had multiple assignment, randomized, or open-label designs. Treatment was the most common study objective (73%) with pharmacological therapy being the most commonly studied intervention., Conclusions: The main reasons for early discontinuation of clinical trials in HPB surgery are poor patient recruitment and inadequate funding. Improved trial design, recruitment strategies and increased funding are needed to prevent trial discontinuation and increase publication rates of HPB surgery clinical trials., (© 2022. The Society for Surgery of the Alimentary Tract.)