PyloResPres: Pylorus resection versus pylorus preservation in pancreaticoduodenectomy. A randomized registry-based multicenter trial from the German DGAV-StuDoQ Pancreas registry

惠普尔手术(部分胰腺十二指肠切除术)被认为是治疗胰头癌和包括慢性胰腺炎在内的其他胰头疾病的标准手术。胃排空延迟(DGE)是PD后一种严重而常见的并发症。因此，DGE导致胰腺癌患者的生活质量受损，住院时间延长，更重要的是，可能会推迟辅助化疗。为了进行PD手术，建立了两种胃切除策略：保留胃幽门(PPPD)或切除胃幽门(PRPD)，后者是预防DGE的一种策略。然而，在指数操作后30天内比较PRPD和PPPD的DGE的研究仍然没有定论。没有大型多中心随机对照试验(RCT)比较PRPD和PPPD之间的总体DGE发生率。拟议的RCT将填补这一空白。这是一种基于多中心登记的随机对照试验(RRCT)，它解决了德国现实世界环境中的相对有效性问题，并允许增强研究结果的普遍性、低成本、快速连续登记和对参考人群进行潜在的完整性随访。德国全科和内脏外科学会(DGAV)建立了高质量的国家胰腺外科注册(StuDoQ|胰腺)，用于胰腺手术的质量控制、风险评估和结果研究，RCT将嵌入其中。这项试验包括18岁的患者，≥计划为任何适应症的PD。主要终点是30天内DGE发生率的差异。次要终点是癌症患者30天的死亡率、发病率、出血量、住院时间、吻合口功能不全、手术时间和开始辅助治疗。共有982名患者将采用两阶段分组序贯设计随机分为PRPP或PPPD两组。这项试验计划提供所需的证据，以决定应该采用哪种切除策略。

The Whipple procedure (partial pancreatoduodenectomy (PD)) is considered to be the standard operation for pancreatic head cancer and other disease of the pancreatic head including chronic pancreatitis. Delayed gastric emptying (DGE) is a serious and common complication occurring after PD. Herein, DGE leads to impaired quality of life, prolonged hospital stay, and more importantly, potentially delays an adjuvant chemotherapy in pancreatic cancer patients. In order to perform a PD procedure, two gastric resection strategies are established: preservation (ppPD) or resection (prPD) of the gastric pylorus, the latter established as a strategy for DGE prevention. However, studies comparing prPD versus ppPD regarding DGE within 30 days after index operation are still inconclusive. No large multicentre randomized controlled trial (RCT) compares the overall DGE rate between prPD and ppPD. The proposed RCT will fill this gap. It is a prospective multicentre registry-based RCT (RRCT) which addresses comparative effectiveness in a German real world setting and allows enhanced generalisability of findings, low costs, rapid consecutive enrollment and the potential completeness of follow-up for the reference population. The German Society for General and Visceral Surgery (DGAV) established the high-quality national pancreatic surgery registry (StuDoQ|Pancreas) for quality control, risk assessment and outcomes research in pancreatic surgery in which the RCT will be embedded. The trial includes patients ≥18 years of age scheduled for PD for any indication. Primary endpoint is the difference in incidence of DGE within 30 days. The secondary endpoints are 30-day mortality, morbidity, blood loss, hospital stay, anastomotic insufficiency, operation time, and initiation of an adjuvant therapy in cancer patients. A total of 982 patients will be randomized for prPP or ppPD using a two-stage group- sequential design. The trial is planned to provide the evidence needed to decide which resection strategy should be applied.