The Norwegian Pancreas Transplantation (PTx) Study

Launched by OSLO UNIVERSITY HOSPITAL · Oct 7, 2013

Keywords

ClinConnect Summary

1. INTRODUCTION AND BACKGROUND

The first pancreas transplantation (PTx) was performed in Minnesota in 1966 by Kelly and colleagues (1). In recent years the number of procedures has grown considerably worldwide, and is now a well established treatment option for patients with diabetes mellitus with and without concomitant diabetic End-Stage Renal Disease (ESRD) (2-4). The indication for PTx is advanced and/or badly controlled diabetes mellitus ("brittle" diabetes, severe hypoglycemic episodes, "unawareness", etc). Solitary pancreas transplantation (SPT; without concomitant kidney transpl...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Patients who receive a primary or secondary pancreas transplant, with or without a simultaneous kidney transplant (SPK).
• • Women who are of childbearing potential must have a negative serum pregnancy test at baseline.
• • Operability has to be ascertained by preoperative examination, performed by nephrologist, transplant surgeon and anaesthesiologist.
• • Signed and dated informed consent form.
• Exclusion Criteria:
• • Evidence of systemic infection
• • Presence of unstable cardiovascular disease.
• • Malignancy \< 5 years prior to entry into the trial (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin).
• • Panel-reactive antibodies (PRA) \> 20% or the presence of donor-specific antigens (DSA).
• • Any positive test for HBV, HBC or HIV.