NCT05843877

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Periampullary Cancer
• Postoperative Pancreatic Fistula

Interventions

Type	Name	Description
BIOLOGICAL	Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy	Islet 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.
PROCEDURE	Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)	As 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.

Timeline

• Start date: 2025-01-28
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2023-05-06
• Last updated: 2026-01-30

Locations

1 site across 1 country: Germany