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首页> 外文期刊>Endoscopy International Open >Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study
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Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study

机译：壶腹周围肿瘤患者术前用塑料或自膨式金属支架进行胆道引流：一项随机临床研究的结果

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Background and study aims Preoperative biliary drainage in patients with periampullary tumors and jaundice has been popularized to improve the quality of life and minimize the risks associated with subsequent radical surgery. The aim of this study was to investigate the possible superiority of self-expandable metal stents (SEMS) over plastic stents, by comparing the amount of bacteria in intraoperatively collected bile and using this variable as a proxy for the efficacy of the respective biliary drainage modalities. Patients and methods In this randomized clinical trial, 92 patients with obstructive jaundice were enrolled; 45 were allocated to the plastic stent group and 47 to the SEMS group.?The primary outcome was the extent and magnitude of biliary bacterial growth at the time of surgical exploration. Secondary outcomes were: macroscopic grading of inflammation of the stented bile ducts, occurrence of adverse events after stenting, stent dysfunction, recognized surgical complexities, and incidence of postoperative complications. Results The patients were well matched regarding clinical and disease-specific characteristics. At surgery, there were no group differences in the bacterial amount and composition of the bile cultures or the perceived difficulty of surgical dissection. During the preoperative biliary drainage period, more instances of stent dysfunction requiring stent replacement were recorded in the plastic stent group (19?% vs. 0?%; P =?0.03). Postoperative complications in patients who underwent curative surgery were more common in patients with plastic stents (72?% vs. 52?%), among which clinically significant leakage from the pancreatic anastomoses seemed to predominate (12?% vs. 3.7?%); however, none of these differences in postoperative adverse events reached statistical significance. Conclusion This randomized clinical study was unable to demonstrate any superiority of SEMS in the efficacy of preoperative bile drainage, as assessed by the amount of bacteria in the intraoperatively collected bile. However, some data in favor of SEMS were observed among the clinical secondary outcomes variables (preoperative stent exchange rates) without increases in local inflammatory reactions. Trial registered at ClinicalTrials.gov (NCT00501176).
机译：背景和研究目标壶腹周围肿瘤和黄疸患者的术前胆道引流术已得到普及，以改善生活质量并最大程度地减少后续根治性手术的风险。这项研究的目的是通过比较术中收集的胆汁中细菌的数量，并使用该变量作为各自胆道引流方式的疗效的代用品，研究自膨胀金属支架（SEMS）优于塑料支架的优越性。 。患者和方法在这项随机临床试验中，纳入了92例梗阻性黄疸患者。其中45例分配到了塑料支架组，47例分配到了SEMS组。主要结果是手术探查时胆道细菌生长的程度和程度。次要结果是：在宏观上对支架胆管的炎症分级，支架后不良事件的发生，支架功能障碍，公认的手术复杂性以及术后并发症的发生率。结果患者在临床和疾病特定特征方面匹配良好。手术时，胆汁培养物的细菌数量和组成或手术剥离的难度没有群体差异。在术前胆道引流期间，在塑料支架组中记录了更多需要更换支架的支架功能异常的病例（19 %% vs. 0 %%; P =？0.03）。接受根治性手术的患者术后并发症在以塑料支架置入的患者中更为常见（72％vs. 52％），其中从胰吻合口漏出的临床显着性似乎占主导地位（12 %% vs. 3.7％）。然而，这些术后不良事件的差异均未达到统计学意义。结论：根据术中收集的胆汁中细菌数量评估，该随机临床研究无法证明SEMS在术前胆汁引流功效方面具有任何优势。但是，在临床次要结局变量（术前支架更换率）中观察到了一些支持SEMS的数据，但并未增加局部炎症反应。在ClinicalTrials.gov（NCT00501176）上注册的试验。

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