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

NCT05843877 Phase 3 RECRUITING

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.

Details

Lead sponsor	Technische Universität Dresden
Phase	Phase 3
Status	RECRUITING
Enrolment	32
Start date	2025-01-28
Completion	2028-01

Conditions

• Periampullary Cancer
• Postoperative Pancreatic Fistula

Interventions

• Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy
• Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

Primary outcomes

• Duration between surgery and time "fit for adjuvant treatment" (postoperative day X) — From day of discharge until confirmed fitness for adjuvant treatment or 24 months, whichever came first
  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

Countries

Germany