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

• Applicant: Professor Dr. Jens Werner
• Subject Area: General and Visceral Surgery
• Term: from 2019 to 2023
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 340731588

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.

• DFG Programme: Clinical Trials
• Co-Investigator: Privatdozent Dr. Bernhard Renz