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 (XandTX)

Technische Universität Dresden

Status and phase: Enrolling; Phase 3

Conditions: Periampullary Cancer; Postoperative Pancreatic Fistula

Treatments: Procedure: Pancreaticoduodenectomy (classic Whipple or pylorus-preserving); Biological: Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05843877

2023-507773-17-00 (EU Trial (CTIS) Number)

TUD-XandTX-079

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Experimental Therapy

Experimental group

Description:

Total pancreatectomy with autologous islet cell transplantation

Treatment:

Biological: Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Standard Therapy

Other group

Description:

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

Treatment:

Procedure: Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)