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
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
You may not be if
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
Clareo Health | 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
