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AHCPR Health Technology Reviews. Rockville (MD): Agency for Health Care Policy and Research (US); 1992-1995.

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This publication is provided for historical reference only and the information may be out of date.

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11Isolated Pancreas Transplantation

, MD, PhD.

Published: August 1995.


The treatment of insulin-dependent diabetics by transplantation of the pancreas has beome more successful since the introduction of cyclosporine A as an immunosuppressant in 1979.(1). The best graft survival results have been obtained in diabetic patients with end-stage renal disease where the pancreas was transplanted as a combined simultaneous pancreas-kidney (SPK) transplant. Although isolated pancreas transplants have also been done as SPK transplants. The transplantation of the pancreas alone in nonuremic diabetics has raised some questions about the risks and benefits of substituting immunosuppressant theraphy for insulin injections. In addition, the poorer graft survival with isolated pancreas transplants (pancreas transplant alone (PTA) or pancreas-after-kidney (PAK) transplants) has also been of concern. The Office of Health Technology Assessment recently completed the assessment of SPK and PAK transplants,(2). and this report reviews the available information concerning the safety, effectiveness, and clinical appropriateness of isolated pancreas transplantation in nonuremic patients with insulin-dependent diabetes mellitus (IDDM).


Insulin-dependent diabetes mellitus is a common disease that is recognized as a major cause of end-stage renal disease, cardiovascular disease, and blindness. Individuals with IDDM usually have shortened life spans and many have a lower quality of life due to the difficulty of managing the diabetes with insulin injections and diet or from the complications that develop with time. Although insulin has prolonged the lives of diabetics, conventional insulin therapy has not prevented the onset of the secondary complications of diabetes. Improvement in the treatment of diabetics has been made over the years with the use of improved insulin preparations and/or changes in insulin injection schedules,(3). but these have been relatively unsuccessful in maintaining normal blood glucose levels and preventing the eventual development of diabetic complications. Recently, intensive insulin therapy with multiple daily insulin injections or insulin administration with a constant infusion pump was shown to be relatively effective in maintaining the blood sugar and hemoglobin A1c at near normal levels. (4). The results indicated that the better control of blood sugar appeared to prevent the development of some of the diabetic complications, but was accompanied by a higher incidence of hypoglycemic episodes in these patients.

Experience has accumulated over the past 10-15 years to indicate that normoglycemia and apparent normalization of glucose metabolism can be restored in diabetics by pancreas transplantation.(5). Independence from insulin injections and avoidance of the adverse effects of intensive insulin therapy have been observed with successful pancreas transplants in some diabetics.(6). Whether the transplants will restore full health and function and prevent the development of diabetic complications in these patients is not known at this time.(7,8).

For this review, data obtained from the United Network for Organ Sharing (UNOS) and data from the published literature were analyzed. References included those found by computer searches of the biomedical databases, those in recent publications, and those appearing as cited references. The most recent report and/or one containing relevant information were selected for inclusion in this review when there was a series of publications from a transplant center that periodically presented cumulative data over several years.

United Network for Organ Sharing organ transplant registry data

Between October 1, 1987, and December 31, 1993, there were a total of 3,072 cadaveric pancreas transplants recorded in the organ transplant registry maintained by UNOS. Of these, 2,604 (85 percent) were transplanted as SPK transplants, 401 (13 percent) as isolated pancreas transplants, and the remaining 68 (2 percent) in combination with other organ transplants. As shown in Figure 1, about 50-100 isolated pancreas transplants have been performed per year. Although 162 (40 percent) of the isolated pancreas transplants were done at the University of Minnesota transplant center, none of the other transplant centers had done more than 24 during this period. The distribution of the limited experiences at transplant centers other than at the University of Minnesota is shown in Figure 2. Only six centers had done 10-24 transplants, whereas 26 other centers had done fewer than 10 transplants.

Figure 1. Number of isolated pancreas transplantations done annually.


Figure 1. Number of isolated pancreas transplantations done annually.

Figure 2. The number of isolated pancreas transplants done at various transplant centers.


Figure 2. The number of isolated pancreas transplants done at various transplant centers.

Survival of recipients and grafts

According to the UNOS organ transplant registry data, the survival of the recipients of the pancreas transplants was essentially the same for all categories of pancreas recipients over a 3-year followup. One-year patient survival was 90.3 percent for those receiving SPK and 91.3 percent for those receiving isolated pancreas transplants (PAK or PTA), whereas the 3-year survival rates were 80.8 percent and 80. 1 percent for the respective recipients.

In contrast, the survival of the transplanted pancreas grafts did depend upon whether the pancreas was transplanted alone or simultaneously with the kidney. Pancreases transplanted simultaneously with a kidney had a survival rate of about 75 percent at 1 year and about 65 percent at 3 years, whereas the survival of isolated pancreas grafts (PTA or PAK) was about 50 percent at 1 year and about 30 percent at 3 years (Figure 3).

Figure 3. Comparison of survival of isolated pancreas transplants and as SPK transplants.


Figure 3. Comparison of survival of isolated pancreas transplants and as SPK transplants.

The data also suggest that the survival of isolated pancreas grafts appeared to decrease with each succeeding year in which the transplantation was done. Figure 4 shows the 3-year survival curves for transplants done in each of 4 succeeding years. Although all of the survival curves were similar in shape, there was a suggestion that the survivals were poorer for transplants done in each succeeding year. The decrease in graft survival with year of transplant became apparent when the 1-2, and 3-year graft survivals were compared against the year the transplant was done (Figure 5). The declining slopes of the lines indicate that the survival rates of grafts are worse with each succeeding year that the transplant was done. One-year graft survival declined from a high of about 55 percent for those done in 1987 to about 50 percent for those done in 1991. Greater declines in graft survival are seen at the 2-and 3-year points for isolated pancreas transplant done in successive years to a low of about 35 percent survival at 2 years and about 15 percent survival at 3 years for transplants done in 1991. (The latter survival rate was based on the reporting of about two-thirds of isolated transplants done in 1991.) In contrast, the pancreas survival rates for SPK transplants done during this same period showed the expected positive slope or increase in survival rates for transplants done in each succeeding year (Figure 6), except for the 3-year survival (based on about one-quarter of the SPK transplants done in 1991) of transplants done in 1991.

Figure 4. The 1-, 2-, and 3-year survival of isolated pancreas transplants.


Figure 4. The 1-, 2-, and 3-year survival of isolated pancreas transplants.

Figure 5. Changes in the 1-,2-, and 3-year survivals of isolated pancreas transplants.


Figure 5. Changes in the 1-,2-, and 3-year survivals of isolated pancreas transplants.

Figure 6. Changes in the 1-,2-, and 3-year survivals of pancreases transplanted as SPK transplants.


Figure 6. Changes in the 1-,2-, and 3-year survivals of pancreases transplanted as SPK transplants.

Published reports of experiences with pancreas transplantation at some centers are presented in Table 1.

Table 1. Graft survival rates for isolated pancreas transplants.


Table 1. Graft survival rates for isolated pancreas transplants.

The overwhelming number of isolated pancreas transplantations that have been performed to date were done by Sutherland's group at the University of Minnesota,(10). with only limited numbers of PTA or PAK transplants having been done at other centers. Because most of the transplants were done at the University of Minnesota, the similarity of the 1-year actuarial survival rate of 54 percent for PTA grafts reported by Sutherland et al(10). to the 1-year survival rate of 50 percent from the UNOS registry data is not unexpected. Other reported survival values have varied over a wide range; 0-48 percent for PTA(11,13,14). and 17-72 percent for PAK transplant.(11,12,14). -(17). With the exception of that reported for PAK transplants by Sollinger et al, (17). the survival rates are similar to or worse than those noted in the UNOS registry data. In all cases, the pancreas grafts done as isolated pancreas transplants had a significantly poorer survival rate than those simultaneously transplanted with kidneys. According to the graph of survival of the grafts presented by Sutherland et al,(18). pancreases transplanted at Minnesota as PTA or PAK transplants had a 1-year actuarial survival rate of about 50 percent and a 3-year survival rate of about 35 percent, compared with a 1-year survival rate of about 60 percent and a 3-year rate of about 50 percent for SPK transplants.

Factors influencing pancreas graft survival

The volume of organ transplants performed at a center has been shown to influence the outcomes of the transplanted grafts. Hunsicker et all(19). analyzed the UNOS collection of organ transplant data for all transplants performed within the United States from October 1, 1987, through December 31, 1989, and reported on the effect of center size and patient-mix covariates on transplant center-specific patient and graft survival in the United States. They foud that, except for the kidney transplants, the graft survival outcomes were significantly poorer in centers of the smallest quintile based upon center volume. In the case of the small number of pancreas transplants that had been done, the risk of graft failure in centers performing fewer than 11 transplants (sum of PTA and PAK and SPK transplants) over 27 months was double the risk of failure for centers doing more than 18 transplants.

A variety of complications that were associated with the transplantation of the pancreas occurred in about 16 percent of patients.(20-23). Among those frequently reported were wound infection, venous and arterial thrombosis of the graft, paralytic ileus, pancreatitis, exocrine leakage, intra-abdominal bleeding, hematuria, and urinary tract infection. Complications such as graft vessel thrombosis, pancreatitis, and infection have led to a relatively high rate of graft loss within the first month of transplantation.(24-28). These early graft losses or "technical failures" occurred frequently with pancreas transplants, whether they were done as SPK or PAK transplants, or PTA. Sutherland et al(29,30). reported technical failure rates of 23.8 percent for SPK transplants, 23. 5 percent for PAk transplants, and 17.6 percent for PTA for pancreas transplants done during the 1984-1991 period and 27 percent for SPK transplants, 26 percent for PAK transplants, and 9 percent for PTA (reported as insignificantly different from the other percentages(30). done in the 1986-1993 period, which suggested that the technical failure rate for pancreas transplant had not decreased with experience. Sutherland et al(9). also found, shown in Table 1, that the technical failure rate for a pancreas from a living related donor (LRD) was higher than that for a cadaveric pancreas. The technical failure rate also increased if the SPK transplant recipient was more than 45 years of age,(24-26). but it did not increase in older recipients of isolated pancreas transplants.

Other factors that appeared to influence the survival of pancreas grafts included human lymphocyte antigen (HLA) matching,(18,19). pancreas recipient category (SPK or PAK transplant, or PTA), immunosuppression regimen,(31,32). and age.(33). Graft survival was better in all recipient categories if a pancreas had zero or one HLA mismatch as compared with one with more than two HLA mismatches, but HLA matching did not appear to have any influence on the incidence of technical failures.(33). Retransplant grafts had decreased survival rates in patients who had originally received SPK or PAK transplants, but not in those who had received a PTA.(24,34). Although successful LRD grafts appeared to have a longer functional survival than cadaveric grafts, LRD grafts suffered from a much higher rate of graft loss due to technical failure. (9).

There were suggestions that the timing and amount of immunosuppresants used might have improved the survival of pancreas grafts. Although some of the increased rejection episodes in nonuremic patients may have been due to the absence of the immunosuppressive effect of uremia, the hypothetical "higher immunogenicity" of the pancreas may have been implicated by the differences in the incidence of rejection episodes that were reported as 96 percent for PTA, 75 percent for PAK transplant, 61-71 percent for SPK transplant, and 46 percent for kidney transplant alone.(35).


Pancreas transplantation represents an alternative means of treating insulin-dependent diabetics. Reasonably successful outcomes with pancreas transplants have been achieved recently and have allowed independence from insulin injections in some diabetics. The bulk of the experiences (>85 percent) have involved pancreases transplanted simultaneously with the kidney in uremic diabetics. Only about 10 percent of the pancreas transplants were done as an isolated pancreas transplant, either PTA or PAK. The survival of the grafts was significantly different depending upon whether the pancreas was part of an SPK transplant or was transplants alone. Pancreas grafts in SPK transplants had a 1-year survival rate fo about 75 percent and a 3-year survival rate of 65 percent, and grafts in isolated pancreas transplants had corresponding survival rates of about 50 percent and 30 percent, respectively. Because outcomes of organ transplants seem to improve with experience, the small number of isolated pancreas transplants done may be contributing to the relatively poor survival rates. However, the similarly poor outcomes for isolated pancreas transplants (over 200) done at the University of Minnesota(8). suggest that the survival of the isolated pancreas transplant involves more than experience.

Although more pancreas transplants are being done, there are difficulties with pancreas transplants that need to be addressed. For example, the high technical failure rate(29). that accounts for a 10-30 percent loss of grafts in all pancreas transplants within the first month and an even higher rate of technical failure for an LRD pancreas transplant(9). have not decreased with experience. Although Sutherland et al(18). noted that the technical failure rates did not decrease with experience, they did find that the overall survival of pancreas transplants improved with each succeeding "era." They found that the 1-year survival rates improved from about 30 percent in the 1976-1986 era to about 50 percent for isolated pancreas transplants done in the 1896-1992 era.(29). The data from the UNOS registry (Figure 6) also indicate that there appeared to be an improvement in survival of pancreas grafts in SPK transplants with experience. The outcomes improved with each succeeding year of transplant from 1987 through 1991 for the 1-and 2-year survival outcomes. The decrease in the 3-year survival of the SPK transplants done in 1991 may not represents a true decrease, because the rate was calculated from the 3-year followup data on only about one quarter of the 1991 However, the decreases in survival of isolated pancreas transplants that were done in each succeeding year (Figure 5) indicate that pancreas transplants may present difficulties that are more complex than those encountered with other organs. The success or failure of pancreas transplants may depend upon solving the illusive nature of the possible higher immunogenicity and "fragility" of the pancreas.

A major issue that is associated with any tissue or organ transplantation is the commitment of the recipient to immunosuppressant therapy for as long as the transplant remains functional. Infections are common with immunosuppression, and cancers have been seen in some immunosuppressed transplant recipients. Although the use of immunosuppressants may not be a factor for patients receiving pancreas transplants along with the kidney or after a kidney transplant because of the immunosuppressant requirements of the kidney transplant, it is of concern to patients who receive pancreas transplants alone because they will be exchanging the use of immunosuppressants for insulin injections. Before this exchange is made, consideration might be given to the chronic administration of cyclosporine A which has been shown to cause chronic injury to the renal microvessels that is rarely reversible and potentially progressive.(36). Of further concern may be the need for more immunosupppression after pancreas transplantation, compared with that required after the transplantation of heart, liver, of kidney allografts, that may be due to the greater immune response in nonuremic recipients.(37).

A possibly higher immunogenicity of the pancreas may be responsible for the greater incidence of rejection episodes and the need for increased amounts of immunosuppressants when a pancreas transplant is added to a kidney transplant. This would appear to be supported by the observation that there was a progressive increase in the incidence of graft rejection episodes with the addition of a pancreas graft.(35). On the other hand, the increased tendency for graft rejection in patients undergoing PTA over those undergoing SPK transplant may reflect the higher immunocompetence of nonuremic patients or may be due to the difficulty in monitoring for graft rejection in the absence of a kidney graft. Therefore, the longer survival of the pancreas graft in SPK transplant recipients would appear to be the combined result of the suppression of the immune system with uremia and the prompt treatment of rejection that is detected earlier with the kidney transplants.

Several sources(8,10,13,38-40). have suggested selection criteria for nonuremic, insulin-dependent diabetics for PTA. All suggested that patients with hyperlabile diabetes who have a history of frequent, severe episodes of hyperglycemic ketoacidosis or hypoglycemia that required intervention or assistance at a medical facility might be considered for a pancreas transplant. This would seem reasonable if these episodes severely compromised the quality of life or were life-threatening to the diabetic. However, observations such as that made by Kent et al(41). in a 10-year followup study of 26 "brittle insulin-dependent" diabetics raise questions about whether such diabetics can be identified. Five of the patients (19 percent) died of probable diabetic complications during the study period. Significantly, only 2 (10 percent) of the 21 surviving diabetics were considered brittle at the end of the 10 years. Without further information, these observations appear to suggest that brittle diabetics may be at higher risk of death, but do not allow the differentiation of these patients from those who become "stable" diabetics on the basis of their diabetic characteristics. In other words, these observations illustrate the difficulty of identifying a difficult-to-manage diabetic who may be at risk and benefit from a pancreas transplant. Documentation of the bases for the episodes of hyperglycemic ketoacidosis(42). or hypoglycemia (especially if the patient is unaware of its onset)(43). and aggressive efforts to control the diabetes would be desirable before considering a pancreas transplant with its attendant risks of death and complications (resulting from surgery and immunosuppressant theraphy) and a relatively poor graft survival outcome.

The high cost for pancreas transplantation and the cost and adverse effects of chronic immunosuppressant theraphy, along with the relatively poor graft survival outcome, would discourage the use of pancreas transplants as an alternative theraphy in nonuremic IDDM patients, except in those who lives are threatened by the lability and severity of their diabetes. The median charge for pancreas transplants done in 1988 was $66,917.(44). This included a median charge of $15,400 for the procurement of the pancreas,(45). which has increased to a mean total 1st-year cost for pancreas transplant of $94,000 ($51,000-$135,000), including charges of $7,000-$15,000 for immunosuppressive drugs for the year, according to the charge data for 1992 obtained from the Health Care Finance Administration. These charges might be compared with the average charge allowed in 1992 of about $6,500 for the hospital treatment of an episode of diabetic complications experienced by diabetics on insulin theraphy. The annual cost of caring for the diabetic would be a minor factor in the few diabetics whose lives are constantly being threatened by the complications arising from the extreme difficulty in managing their diabetes. More important to the diabetic are the risks of death and morbidity associated with pancreas transplantation, and that there is only about a 35 percent chance that the graft will survive 3 years.


Pancreas transplants have been successfully performed and have effectively freed some diabetics from dependence on insulin injections. Most of the transplants have been done as simultaneous pancreas-kidney transplants. Only a small fraction have been done as isolated pancreas transplants in nonuremic diabetics or in diabetics who already had a kidney transplant. The survival of grafts that are transplanted as isolated pancreas transplants has been relatively poor when compared with the survival of grafts transplanted as SPK transplants. The transplantation of the pancreas appears to be more complicated than the transplantation of other organs in that there are more surgical complications and some of these are responsible for a relatively high percentage of the grafts being lost (technical failures) during the perioperative period. Further study of these problems and other aspects of pancreas transplantation, such as the modification of the immunosuppressants used, may be desirable and may result in better outcomes, Pancreas transplants in nonuremic diabetics can be done with limited success, but there are currently insufficient data to ascertain the clinical appropriateness of pancreas transplants in these patients.


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AHCPR Pub. No. 95-0068


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