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Partial or total removal of the pancreas and transplantation of the patient's own islet cells in patients with pancreatic cancer and a high risk to develop fistulas (leaks) after surgery
EU CTIS ID: 2023-507773-17-00
What this study is testing
To obtain first data on the treatment effect of primary total pancreatectomy with simultaneous autologous islet transplantation in patients with periampullary carcinoma and high-risk profile for the development of postoperative pancreatic fistulae (POPF).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female patients ≥18 years
- Suspicion of or confirmed diagnosis of periampullary cancer and indication for pylorus preserving pancreaticoduodenectomy (PPPD) or Whipple surgery
- 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)
- Written informed consent after clarification
You likely can't join if
- Patients planned for an additional surgery besides the PPD or Whipple surgery
- Simultaneous participation in another interventional clinical trial (up to 4 weeks before enrolment)
- Addiction or other concomitant diseases, which prevent the participant from understanding and comprehending the scope, nature and potential consequences of the clinical trial
- Pregnant or lactating women
- 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
- Any indication that the participant is unlikely to adhere to the protocol (i.e. lack of compliance)
See the full eligibility criteria
- Male and female patients ≥18 years
- Suspicion of or confirmed diagnosis of periampullary cancer and indication for pylorus preserving pancreaticoduodenectomy (PPPD) or Whipple surgery
- 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)
- Written informed consent after clarification
- Patients planned for an additional surgery besides the PPD or Whipple surgery
- Simultaneous participation in another interventional clinical trial (up to 4 weeks before enrolment)
- Addiction or other concomitant diseases, which prevent the participant from understanding and comprehending the scope, nature and potential consequences of the clinical trial
- Pregnant or lactating women
- 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
- Any indication that the participant is unlikely to adhere to the protocol (i.e. lack of compliance)
- Diagnosis of a second primary cancer
- Previous organ- or tissue transplant
- Known HIV infection (HIV antibody test)
- Positivity for Anti-HCV, positive anti-HBsAg or anti-HBc
- Insulin treated diabetes
- Known hypersensitivity towards one of the substances under investigation or its components or substances of similar chemical structure
- Individuals, who are dependent from the sponsor
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.