Pancreatic Head Resection or Total Pancreatectomy With Islet Autotransplantation in Patients With Periampullary Cancer and High Risk Profile for the Development of Postoperative Pancreatic Fistula

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.

Trial Details

NCT ID
NCT05843877
Phase
PHASE3
Sponsor
Technische Universität Dresden
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy
  • Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
Locations (sample)
  • Dresden, Germany|51.05089,13.73832

Key Eligibility Criteria

  • 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 du…
  • written informed consent of the participant after successful Informed consent

For full eligibility, visit ClinicalTrials.gov.

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