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

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2028-01-31

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.

Conditions

Periampullary Cancer; Postoperative Pancreatic Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Therapy

Total pancreatectomy with autologous islet cell transplantation

Group Type: EXPERIMENTAL

Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Intervention Type: BIOLOGICAL

Islet cells are isolated from patients healthy pancreatic tissue. Following total pancreatectomy, these autologous cells are injected into the portal vein, to implant in the liver and produce insulin.

Standard Therapy

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

Group Type: OTHER

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

Intervention Type: PROCEDURE

As a standard procedure, the tumor-affected region of the pancreatic head with surrounding tissue and lymph nodes is removed during surgery. Reconstruction is performed by pancreaticojejunostomy.

Interventions

Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Islet cells are isolated from patients healthy pancreatic tissue. Following total pancreatectomy, these autologous cells are injected into the portal vein, to implant in the liver and produce insulin.

Intervention Type: BIOLOGICAL

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

As a standard procedure, the tumor-affected region of the pancreatic head with surrounding tissue and lymph nodes is removed during surgery. Reconstruction is performed by pancreaticojejunostomy.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Cancer Research Center

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Ludwig, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of internal Medicine III

Marius Distler, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Visceral, Thoracic and Vascular Surgery

Locations

University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Barbara Ludwig, Prof. Dr.

Role: CONTACT

barbara.ludwig@ukdd.de

+49 458

References

Hempel S, Kolbinger FR, Oehme F, Radulova-Mauersberger O, Schmid J, Schubert U, Schepp F, Bornstein S, Korn S, Trips E, Weitz J, Distler M, Ludwig B. Pancreatoduodenectomy versus total pancreatectomy and simultaneous intraportal islet autotransplantation for periampullary cancer at high-risk of postoperative pancreatic fistula (XANDTX-trial): Protocol of a randomized controlled pilot trial. PLoS One. 2025 Jul 28;20(7):e0327949. doi: 10.1371/journal.pone.0327949. eCollection 2025.

Reference Type: DERIVED

PMID: 40720532 (View on PubMed)

Other Identifiers

2023-507773-17-00

Identifier Type: CTIS

Identifier Source: secondary_id

TUD-XandTX-079

Identifier Type: -

Identifier Source: org_study_id