NCT05843877 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
| NCT ID | NCT05843877 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Technische Universität Dresden |
| Condition | Periampullary Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-01-28 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 32 participants in total. It began in 2025-01-28 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Barbara Ludwig, Prof. Dr.
PRINCIPAL INVESTIGATOR
Department of internal Medicine III
Frequently Asked Questions
Who can join the NCT05843877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periampullary Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05843877 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 32 participants.
Is NCT05843877 currently recruiting?
Yes, NCT05843877 is actively recruiting participants. Contact the research team at barbara.ludwig@ukdd.de for enrollment information.
Where is the NCT05843877 trial being conducted?
This trial is being conducted at Dresden, Germany.
Who is sponsoring the NCT05843877 clinical trial?
NCT05843877 is sponsored by Technische Universität Dresden. The principal investigator is Barbara Ludwig, Prof. Dr. at Department of internal Medicine III. The trial plans to enroll 32 participants.
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