Spectrum of surgical complications after simultaneous pancreas-kidney transplantation in a prospectively randomized study of two immunosuppressive protocols.

Abstract

BACKGROUND:

Simultaneous pancreas-kidney transplantation (SPK) has evolved as an effective treatment for patients with end-stage nephropathy due to type 1 diabetes mellitus. This report analyses the spectrum of surgical complications among patients receiving tacrolimus and cyclosporin microemulsion (ME)-based therapy for SPK transplantation.

METHODS:

The analysis included 205 patients randomly assigned to tacrolimus (n = 103) or cyclosporin-ME (n = 102) in the Euro-SPK 001 study. Surgical complications were defined as any intervention in the 3-month post-operative course related to the transplant procedure.

RESULTS:

In the tacrolimus vs cyclosporin-ME group, repeat laparotomy was required by fewer patients (26 vs 43%, respectively; P = 0.01) and at a later stage post-transplant (26+/-26 vs 14+/-17 days; P = 0.05). Also, thrombosis of graft vessels (2 vs 9%; P = 0.03) and repeat laparotomy for intra-abdominal haemorrhage within the first 3 months (8 vs 22%; P = 0.005) occurred significantly less frequently with tacrolimus vs cyclosporin-ME. A donor age of > or =45 years was a significant determinant for surgical complications requiring repeat laparotomy, regardless of the type of immunosuppression. Portal anastomosis was the safest method of endocrine venous drainage, and Roux-en-Y loop for enteric exocrine drainage was associated with a higher re-operation rate than duodenoenterostomy. Repeat laparotomy had no impact on patient survival, but significantly reduced kidney and pancreas graft survival in the cyclosporin-ME group (kidney: P<0.01; pancreas: P<0.001) and in both groups combined (P < or = 0.05 and P<0.001, respectively).

CONCLUSIONS:

The immunological benefits of tacrolimus compared with cyclosporin-ME treatment result in a lower incidence of repeat laparotomies post-transplant and a reduced in-hospital stay. Fewer repeat laparotomies translate into improved pancreas and kidney graft survival.

• Authors: Wolfgang Steurer, Jacques Malaise, Walter Mark, Alfred Koenigsrainer, Raimund Margreiter, Euro-SPK Study Group
• Journal: Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association (Nephrol Dial Transplant) Vol. 20 Suppl 2 Pg. ii54-62 (May 2005) ISSN: 0931-0509 [Print] England
• PMID: 15814551 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Immunosuppressive Agents
• Cyclosporine
• Tacrolimus

Topics

• Adult
• Age Factors
• Cyclosporine (therapeutic use)
• Diabetes Mellitus, Type 1 (complications, surgery)
• Diabetic Nephropathies (complications, surgery)
• Europe (epidemiology)
• Follow-Up Studies
• Graft Rejection (epidemiology, prevention & control)
• Humans
• Immunosuppressive Agents (therapeutic use)
• Incidence
• Israel (epidemiology)
• Kidney Failure, Chronic (etiology, surgery)
• Kidney Transplantation (adverse effects)
• Laparotomy
• Middle Aged
• Pancreas Transplantation (adverse effects)
• Postoperative Complications (epidemiology, etiology, surgery)
• Prospective Studies
• Reoperation
• Survival Rate
• Tacrolimus (therapeutic use)
• Treatment Outcome