Abstract Background Data on interventions to reduce postoperative pancreatic fistula (POPF) following pancreatoduodenectomy (PD) are conflicting. The aim of this study was to assimilate data from RCTs. Methods MEDLINE and Embase databases were searched systematically for RCTs evaluating interventions to reduce all grades of POPF or clinically relevant (CR) POPF after PD. Meta-analysis was undertaken for interventions investigated in multiple studies. A post hoc analysis of negative RCTs assessed whether these had appropriate statistical power. Results Among 22 interventions (7512 patients, 55 studies), 12 were assessed by multiple studies, and subjected to meta-analysis. Of these, external pancreatic duct drainage was the only intervention associated with reduced rates of both CR-POPF (odds ratio (OR) 0.40, 95 per cent c.i. 0.20 to 0.80) and all-POPF (OR 0.42, 0.25 to 0.70). Ulinastatin was associated with reduced rates of CR-POPF (OR 0.24, 0.06 to 0.93). Invagination (versus duct-to-mucosa) pancreatojejunostomy was associated with reduced rates of all-POPF (OR 0.60, 0.40 to 0.90). Most negative RCTs were found to be underpowered, with post hoc power calculations indicating that interventions would need to reduce the POPF rate to 1 per cent or less in order to achieve 80 per cent power in 16 of 34 (all-POPF) and 19 of 25 (CR-POPF) studies respectively. Conclusion This meta-analysis supports a role for several interventions to reduce POPF after PD. RCTs in this field were often relatively small and underpowered, especially those evaluating CR-POPF.

中文翻译：

---

减少胰十二指肠切除术后胰瘘的围手术期干预：荟萃分析

摘要 背景关于减少胰十二指肠切除术（PD）术后胰瘘（POPF）的干预措施的数据是相互矛盾的。本研究的目的是吸收随机对照试验的数据。 方法系统地检索了 MEDLINE 和 Embase 数据库，以寻找评估干预措施的随机对照试验，以减少 PD 后所有级别的 POPF 或临床相关 (CR) POPF。对多项研究中调查的干预措施进行了荟萃分析。对阴性随机对照试验的事后分析评估了这些试验是否具有适当的统计功效。 结果在 22 项干预措施（7512 名患者，55 项研究）中，其中 12 项经过多项研究评估，并进行荟萃分析。其中，胰外管引流是唯一与 CR-POPF（比值比 (OR) 0.40，95% CI 0.20 至 0.80）和全 POPF（OR 0.42，0.25 至 0.70）发生率降低相关的干预措施。乌司他丁与 CR-POPF 发生率降低相关（OR 0.24、0.06 至 0.93）。内陷式（相对于导管粘膜）胰空肠吻合术与全 POPF 发生率降低相关（OR 0.60、0.40 至 0.90）。大多数负面 RCT 被发现效力不足，事后效力计算表明，干预措施需要将 POPF 率降低至 1% 或更低，才能在 34 项中的 16 项（全 POPF）和 19 项中实现 80% 的效力。分别有 25 项（CR-POPF）研究。 结论该荟萃分析支持多种干预措施在减少 PD 后 POPF 方面的作用。该领域的随机对照试验通常相对较小且动力不足，尤其是那些评估 CR-POPF 的随机对照试验。