Surgery with Islet Autotransplantation for Patients with Pancreatic Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tissue-glue injection into the pancreas during pancreaticoduodenectomy

  This trial will test whether injecting a tissue glue called N-butyl-2-cyanoacrylate into the pancreatic remnant during pancreaticoduodenectomy reduces postoperative pancreatic fistulas in patients with a soft pancreas and a small main duct.

  Recruiting Phase 2 Minia University · Minya, Minya Governorate · NCT07230509

• Saleh's technique: injecting Histoacryl glue into the pancreas during pancreaticojejunostomy

  This procedure will try injecting a tissue glue (Histoacryl) into the pancreas during pancreaticoduodenectomy to see if it reduces pancreatic leaks in people with a soft pancreas and a small pancreatic duct.

  Recruiting Phase 1 Minia University · Minya, Minya Governorate · NCT07132541

• Local complications of acute pancreatitis and postoperative pancreatic fistula: what happens in real life

  This multicenter registry tests how local pancreatic complications are managed in routine care and what outcomes look like over 180 days for adults.

  Recruiting at 12 sites Tokyo University · Ōtsu, Shiga and 11 other locations · NCT07862088

• Tissue adhesive (Glubran®2) to reinforce pancreaticojejunostomy in soft pancreas

  This trial will test whether adding a tissue adhesive glue (Glubran®2) to the pancreatic-jejunal connection reduces postoperative pancreatic leaks in adults with a soft pancreas undergoing pancreaticoduodenectomy.

  Recruiting Minia University · Minya, Minya Governorate · NCT07155525

• Neoadjuvant chemotherapy versus immediate surgery for resectable pancreatic head and periampullary cancer

  This trial tests if giving chemotherapy before surgery helps people with resectable pancreatic head or periampullary cancer live longer than having immediate surgery followed by chemotherapy.

  Recruiting Phase 3 Minia University · Minya, Minya Governorate · NCT07081360

• Predicting pancreatic fistula after pancreaticoduodenectomy

  This project will try to find which before-, during-, and after-surgery factors predict clinically significant pancreatic fistula in adults having pancreaticoduodenectomy for pancreatic or periampullary tumors.

  Recruiting Minia University · Minya · NCT07022015

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.