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

PyloResPres：胰十二指肠切除术中幽门切除与幽门保留。

• 批准号: 340731588
• 负责人: Professor Dr. Jens Werner
• 金额: --
• 依托单位: Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2019
• 资助国家: 德国
• 起止时间: 2018-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/340731588?language=en
• 关键词: PyloResPres; Pylorus; resection; versus; pylorus

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.

维普莱手术（部分胰头切除术（PD））被认为是胰头癌和其他胰头疾病（包括慢性胰腺炎）的标准手术。胃排空延迟（DGE）是PD后常见的严重并发症。在此，DGE导致生活质量受损，住院时间延长，更重要的是，可能延迟胰腺癌患者的辅助化疗。为了进行PD手术，建立了两种胃切除策略：胃幽门的保留（ppPD）或切除（prPD），后者被建立为DGE预防策略。然而，在首次手术后30天内比较prPD与ppPD关于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率。拟议的RCT将填补这一空白。这是一项基于前瞻性多中心登记研究的随机对照试验（RRCT），旨在研究德国真实的世界背景下的比较有效性，并增强了结果的普遍性、低成本、快速连续入组和参考人群随访的潜在完整性。德国普外科和内脏外科学会（DGAV）建立了高质量的国家胰腺外科登记处（StuDoQ|胰腺），用于胰腺手术的质量控制、风险评估和结局研究，其中将嵌入RCT。本试验包括因任何适应症计划PD的≥18岁患者。主要终点是30天内DGE发生率的差异。次要终点是癌症患者的30天死亡率、发病率、失血量、住院时间、吻合口功能不全、手术时间和开始辅助治疗。采用两阶段组序贯设计，将共计982例患者随机分配至prPP或ppPD组。该试验计划提供必要的证据，以决定应采用哪种切除策略。