RecruitingPhase 3NCT05843877

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)

Sponsor

Technische Universität Dresden

Enrollment

32 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

Periampullary Cancer Postoperative Pancreatic Fistula

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria17

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)
positive hepatitis C antibodies, positive hepatitis B surface antigens and hepatitis Bc antibodies
insulin-treated diabetes mellitus
history of hypersensitivity to any of the drugs used or their ingredients or to drugs with a similar chemical structure
concurrent participation in another clinical trial (incl. within the last 4 weeks prior to inclusion).
addiction or other medical conditions that do not allow the subject to understand the nature and not be able to appreciate the nature, scope and possible consequences of the trial
pregnant or breastfeeding women
women of childbearing age, except for women who meet the following criteria:
Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH \> 40 U/ml)
Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy)
Regular and correct use of a contraceptive method with an failure rate \< 1% per year
Sexual abstinence
Vasectomy of the partner
evidence that the patient is unlikely to comply with the protocol

Interventions

BIOLOGICALIntraportal 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.

PROCEDUREPancreaticoduodenectomy (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.