Simultaneous pancreas-kidney transplantation in a large multicenter study: surgical complications.
Simultaneous pancreas-kidney (SPK) transplantation has evolved as an effective treatment modality for patients with end-stage nephropathy owing to type 1 diabetes mellitus. This kidney-pancreas transplant procedure includes a number of risks, one of them being surgical complications, which were analyzed in this large prospective multicenter study.


METHODS
The analysis included 205 patients randomly assigned to tacrolimus (n = 103) or cyclosporine ME (n = 102) in the Euro-SPK001 study. Surgical complications were defined as any intervention in the postoperative course related to the transplant procedure.


RESULTS
The number of patients undergoing relaparotomy was significantly lower among the tacrolimus group (26.2%) as compared to the cyclosporine ME group (43.1%, P = .0109). Relaparotomy was performed earlier in the cyclosporine ME group (day 14 +/- 17) compared to patients in the tacrolimus group (day 26 +/- 26, P = .0506). Graft vessel thrombosis, intra-abdominal hemorrhage, and enteric or ureteral leakage within the first 3 months occurred significantly more frequently in cyclosporine ME-treated patients. Donor age above 45 years showed a negative impact on surgical complications. Relaparotomy had no impact on patient survival but significantly affected pancreas and kidney graft survival in both groups.


CONCLUSIONS
This prospective, randomized, multicenter trial in patients undergoing primary SPK demonstrated a benefit of tacrolimus over cyclosporine ME with regard to the incidence of surgical complications and, consecutively, to kidney and pancreas graft survival.
Malaise
J
J
EUROSPK Central Office, Brussels, Belgium. jacques.malaise@chir.ucl.ac.be
Steurer
W
W
Koenigsrainer
A
A
Mark
W
W
Margreiter
R
R
Van Ophem
D
D
Mourad
M
M
Squifflet
J P
JP
D003922:Diabetes Mellitus, Type 1 / Q000601:surgery; D003928:Diabetic Nephropathies / Q000601:surgery; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000009:adverse effects* / Q000276:immunology; D016035:Pancreas Transplantation / Q000009:adverse effects* / Q000276:immunology; D011183:Postoperative Complications / Q000453:epidemiology*; D012086:Reoperation / Q000706:statistics & numerical data; D016896:Treatment Outcome
D007166:Immunosuppressive Agents