AUTOLOGOUS PANCREATIC ISLETS for Periampullary carcinoma|Pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Male and female patients ≥18 years\n- Suspicion of or confirmed diagnosis of periampullary cancer and indication for pylorus preserving pancreaticoduodenectomy (PPPD) or Whipple surgery\n- High risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreatic tissue and a pancreatic duct diameter <3mm (pre- and intraoperative confirmation)\n- Written informed consent after clarification"}

Exclusion criteria

• {"criterion_text":"- Patients planned for an additional surgery besides the PPD or Whipple surgery\n- Simultaneous participation in another interventional clinical trial (up to 4 weeks before enrolment)\n- Addiction or other concomitant diseases, which prevent the participant from understanding and comprehending the scope, nature and potential consequences of the clinical trial\n- Pregnant or lactating women\n- Women of childbearing potential, except for women who meet at least one of the following criteria: a) Postmenopausal; b) Post-surgery (6 weeks after bilateral ovariectomy, bilateral salpingectomy with or without a hysterectomy); c) Negative pregnancy test (serum) and the willingness to regularly and correctly use a highly effective contraceptive method (Pearl Index <1%); d) Abstinence; e) Partner’s vasectomy\n- Any indication that the participant is unlikely to adhere to the protocol (i.e. lack of compliance)\n- Diagnosis of a second primary cancer\n- Previous organ- or tissue transplant\n- Known HIV infection (HIV antibody test)\n- Positivity for Anti-HCV, positive anti-HBsAg or anti-HBc\n- Insulin treated diabetes\n- Known hypersensitivity towards one of the substances under investigation or its components or substances of similar chemical structure\n- Individuals, who are dependent from the sponsor\n- Individuals of vulnerable groups, such as: a) Adults, who are unable to understand the nature, significance and scope of the clinical trial and who are unable to articulate their will accordingly; b)Individuals, who are unable to give consent; c) Individuals, who are institutionalized by court or official order ; d) Individuals listed under exclusion criteria 12 as well as inclusion criteria 1 and 4"}

Primary endpoints

• {"endpoint_text":"- Duration between surgery and the date of the decision \"fit for adjuvant treatment\" (postoperative day X)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Duration between surgery and the actual start of adjuvant therapy\n- Perioperative morbidity and mortality\n- Number and type of adverse events and serious adverse events\n- Quality of life (post-surgery, EORTC QLQ-C30/Pan26)\n- Metabolic outcome\n- Oncological long term course (60 months)","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

25-03-2024

Latest Decision Or Authorization Date

18-04-2024

Processing Time Days

24

Number Of Sites

1

Number Of Participants

32

Primary sponsor

Full Name

Technische Universitat Dresden

Organisation Type

Educational Institution

Country Of Registered Address

Germany