The primary objective of this clinical trial is to evaluate whether primary total pancreatectomy with simultaneous islet autotransplantation compared with pancreatic head resection (alone) can reduce perioperative morbidity and time to initiation of adjuvant therapy in patients with a high-risk constellation for pancreatic fistulas.
suspected or confirmed periampullary carcinoma (tumor) and indication for PPPD (pylorus-preserving pancreaticoduodenectomy) or Whipple surgery
high-risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreas and Pancreatic duct diameter < 3 mm (preoperative and intraoperative confirmation)
written informed consent of the participant after successful Informed consent
patients on whom another procedure is to be performed simultaneously in addition to PPPD or Whipple surgery
confirmed other primary tumor
previous transplantation of an organ or tissue
known infection with HIV (HIV antibodies)
Technische Universität Dresden
Lead sponsor
German Cancer Research Center
Collaborator