NCT05843877RecruitingPhase 3
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
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)
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 27 Feb 2023
- Start date
- 28 Jan 2025
- Primary completion date
- Jan 2028
- Lead sponsor
- Technische Universität Dresden
- Diseases
- Pancreatic cancer
- NCT number
- NCT05843877
- EU CT number
- 2023-507773-17-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 32
- From 28 Jan 2025 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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
Lab values
- 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
Other
- confirmed other primary tumor
- pregnant or breastfeeding women
- evidence that the patient is unlikely to comply with the protocol
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.