Partial or total removal of the pancreas and transplantation of the patient's own islet cells in patients with pancreatic cancer and a high risk to develop fistulas (leaks) after surgery

Phase 1

• Conditions: Patients with perampullary carcinoma and a high-risk profile to develop postoperative pancreatic fistulas; MedDRA version: 21.0Level: LLTClassification code: 10033604Term: Pancreatic cancer Class: 10029104; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-507773-17-00
• Lead Sponsor: Technische Universitat Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Male and female patients =18 years, Suspicion of or confirmed diagnosis of periampullary cancer and indication for pylorus preserving pancreaticoduodenectomy (PPPD) or Whipple surgery, High risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreatic tissue and a pancreatic duct diameter <3mm (pre- and intraoperative confirmation), Written informed consent after clarification

Exclusion Criteria

Patients planned for an additional surgery besides the PPD or Whipple surgery, Simultaneous participation in another interventional clinical trial (up to 4 weeks before enrolment), Addiction or other concomitant diseases, which prevent the participant from understanding and comprehending the scope, nature and potential consequences of the clinical trial, Pregnant or lactating women, Women of childbearing potential, except for women who meet at least one of the following criteria: a) Postmenopausal; b) Post-surgery (6 weeks after bilateral ovariectomy, bilateral salpingectomy with or without a hysterectomy); c) Negative pregnancy test (serum) and the willingness to regularly and correctly use a highly effective contraceptive method (Pearl Index <1%); d) Abstinence; e) Partner’s vasectomy, Any indication that the participant is unlikely to adhere to the protocol (i.e. lack of compliance), Diagnosis of a second primary cancer, Previous organ- or tissue transplant, Known HIV infection (HIV antibody test), Positivity for Anti-HCV, positive anti-HBsAg or anti-HBc, Insulin treated diabetes, Known hypersensitivity towards one of the substances under investigation or its components or substances of similar chemical structure, Individuals, who are dependent from the sponsor, Individuals of vulnerable groups, such as: a) Adults, who are unable to understand the nature, significance and scope of the clinical trial and who are unable to articulate their will accordingly; b)Individuals, who are unable to give consent; c) Individuals, who are institutionalized by court or official order ; d) Individuals listed under exclusion criteria 12 as well as inclusion criteria 1 and 4

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified