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)
Parallel
Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy
Biological/VaccineIslet cells are isolated from patients healthy pancreatic tissue. Following total pancreatectomy, these autologous cells are injected into the portal vein, to implant in the liver and produce insulin.
Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
Procedure/SurgeryAs a standard procedure, the tumor-affected region of the pancreatic head with surrounding tissue and lymph nodes is removed during surgery. Reconstruction is performed by pancreaticojejunostomy.
Duration between surgery and time "fit for adjuvant treatment" (postoperative day X)
Time (days) between surgery and the date of certified fitness to begin adjuvant therapy, confirmed by an oncology consult, starting at day of discharge, than assessed at POD 90, POD 180, POD 365, 24 months
Comparison of actual start of adjuvant therapy in both arms
Postoperative day on which adjuvant therapy was started
Rate of peri-operative morbidity/mortality acc. to Clavien-Dindo classification
Rate of peri-operative morbidity/mortality will be assessed acc. to Clavien-Dindo classification
Rate of (serious) adverse events
Rate of (serious) adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0, 2017)
Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire
The QoL analyses will include QoL mean values, QoL response. EORTC QLQ C30 contains 30 questions28 questions regarding body fitness, daily routines, restrictions at work and hobby, appetite, fatigue, cough, breathlessness, pain, tiredness, and body conditions from (1) to (4); 1 (not a bit), 2 (little), 3 (moderate), 4 (much). 2 questions regarding state of health and Quality of life with a horizontal rating from 1 to 7; 1 (very bad), 7 (excellent).; assessed at POD 90, POD 180, POD 365, and 24 months after surgery
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Technische Universität Dresden
Lead sponsor
German Cancer Research Center
Collaborator
