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

Inclusion 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 duct diameter \< 3 mm (preoperative and intraoperative confirmation)
* written informed consent of the participant after successful Informed consent

Exclusion Criteria:

* 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:

  1. Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH \> 40 U/ml)
  2. Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy)
  3. Regular and correct use of a contraceptive method with an failure rate \< 1% per year
  4. Sexual abstinence
  5. Vasectomy of the partner
* evidence that the patient is unlikely to comply with the protocol