Surgery with Islet Autotransplantation for Patients with Pancreatic Cancer
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)
This study is testing if a surgery that includes removing the whole pancreas and transplanting the patient's own insulin-producing cells can help people with pancreatic cancer avoid complications and start treatment faster compared to just removing part of the pancreas.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Locations | 1 site (Dresden) |
| Trial ID | NCT05843877 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of total pancreatectomy combined with islet autotransplantation compared to pancreatic head resection alone in patients with periampullary cancer who are at high risk for developing postoperative pancreatic fistulas. The study aims to reduce perioperative complications and expedite the start of adjuvant therapy. Participants will undergo either a classic Whipple procedure or pylorus-preserving pancreaticoduodenectomy, followed by the transplantation of their own pancreatic islets. The trial focuses on patients with specific anatomical and health profiles that increase their risk for complications.
Who should consider this trial
Good fit: Ideal candidates are patients with suspected or confirmed periampullary carcinoma who are at high risk for postoperative pancreatic fistula.
Not a fit: Patients with other primary tumors, those requiring additional simultaneous procedures, or those with certain infections or diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications and improve recovery times for patients undergoing surgery for periampullary cancer.
How similar studies have performed: While similar approaches have been explored, this specific combination of total pancreatectomy with islet autotransplantation in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dresden
- University Hospital Carl Gustav Carus Technische Universität Dresden — Dresden, Germany (Recruiting)
Study contacts
- Principal investigator: Barbara Ludwig, Prof. Dr. — Department of internal Medicine III
- Study coordinator: Barbara Ludwig, Prof. Dr.
- Email: barbara.ludwig@ukdd.de
- Phone: +49 458
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.