Pancreas Removal With Islet Transplant for Periampullary Cancer at High Fistula Risk
Tests total pancreas removal with islet transplant versus head resection in adults with periampullary cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Dresden, GermanySee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with suspected or confirmed cancer around the ampulla of the pancreas who need Whipple-type surgery and have a high risk of a pancreatic fistula after it.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Suspected or confirmed periampullary cancer with an indication for pylorus-preserving pancreaticoduodenectomy or Whipple surgery, and a high risk of postoperative pancreatic fistula.
- Earlier treatment
- No previous transplantation of an organ or tissue.
- Biomarker or test result
- Soft pancreas and a pancreatic duct diameter below 3 mm, confirmed before and during surgery.
Main reasons for not taking part
- Another procedure planned at the same time as the Whipple-type surgery
- Another confirmed primary tumor
- Known HIV infection, or positive hepatitis B or C tests
- Diabetes treated with insulin
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Where in Germany
- Technische Universität DresdenDresden, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Technische Universität Dresden
- Trial code
- NCT05843877EU 2023-507773-17-00
- Record updated
- 30 January 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: patients on whom another procedure is to be performed simultaneously in addition to PPPD or Whipple surgery; previous transplantation of an organ or tissue; concurrent participation in another clinical trial (incl. within the last 4 weeks prior to inclusion); 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; 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; 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; confirmed other primary tumor; pregnant or breastfeeding women; evidence that the patient is unlikely to comply with the protocol.