Long term Quality of Life in Pancreas Transplantation
Research type
Research Study
Full title
Cross-sectional Observational Study on Long Term Quality of Life in Pancreas and Pancreas Kidney Transplant Recipients
IRAS ID
251150
Contact name
Peter J Friend
Contact email
Sponsor organisation
University of Oxford/Clinical Trial and Research Governance
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Solid organ Pancreas Transplantation (PT) is a well-established treatment option for people with Insulin Dependent Diabetes. It is offered to a selected cohort of patients deemed fit enough for major surgery. \n\nThe most frequent form of Pancreas Transplantation is Simultaneous Pancreas Kidney Transplantation (SPK), which is offered to patients with end stage renal failure secondary to diabetes. These individuals, already in need of a kidney transplant, could potentially be eligible for a combined operation. \n\nPancreas Transplant Alone (PTA) is offered to relatively fit insulin dependent diabetic patients with preserved renal function who suffer of brittle hypoglycaemia unawareness. This is a condition that is potentially life threatening and justifies the risks of surgery.\n\nThere are other treatment options we can offer these patients: kidney transplant alone (KTA), Islet Transplantation (IT), Simoultaneous Islet and Kidney Transplantation (SIK), Traditional medical management, closed loop insulin systems.\nAll of these options can solve the most urgent clinical needs of the patients (renal failure, hypoglycaemia unawareness) at a lower risk. However, they are also associated with inferior outcomes in the long term.\n\nIn the context of tailoring the correct therapeutical approach for each individual, it is now a shared opinion amongst transplant professional that surgical risks must be weighed against clinical gain and quality of life gain. \nAfter over 50 years of Pancreas Transplantation, long term clinical outcomes have been extensively investigated, but there the long-term impact on quality of life is less known. \n\nOxford Transplant Centre is one of the highest PT volume centres worldwide with over 1000 PT transplants performed in the past two decades. For this reason this is the ideal setting to investigate long term QoL in this population.\n\nIn addition, the research team plans to investigate the impact of the current Covid-19 pandemic on anxiety and depression level in this population \n
Lay summary of study results: This was a study aimed at understanding long term Health Related Quality of Life (HRQOL) after pancreas transplantation in individuals affected by type one diabetes.
It was conducted from August 2021 to April 2022 at Oxford Transplant Centre, the highest pancreas transplant volume centre in the UK, and it was sponsored by the University of Oxford.Background.
Type one diabetes occurs when an individual’s pancreas loses the ability to produce insulin and to use sugar as a source of energy. Consequently, survival depends upon injecting the correct amount of artificial insulin and monitoring blood sugar levels closely.
Both high and low sugar levels can be immediately life threatening. Moreover, poorly controlled diabetes can lead to the development of dangerous and life changing chronic complications, such as stroke, heart disease, blindness, kidney failure to mention a few.
For these reasons, it is of paramount importance to keep blood sugar within the normal range as much as possible. Hence, diabetes has a profound impact on patient’s life both in terms of consequences of the disease and in terms of its management.Medical treatment of diabetes has become increasingly successful thanks to innovative devices that deliver insulin and monitor blood sugars simultaneously. However, the ideal solution would be restoring one’s ability to produce insulin naturally and therefore to maintain glucose levels within the normal range.
Currently, this is only possible by giving patients a new pancreas, either as a whole organ (Pancreas Transplantation) or as an infusion of pancreatic cells within the liver (Islet Transplantation).
Of the two options, solid organ pancreas transplantation has been, so far, the most successful in terms of duration of insulin independence. In other words, although the surgical approach is the highest risk procedure, it is also the strategy with the highest chance of long-lasting results.The surgical risks of pancreas transplantation are traditionally weighted against potential clinical benefits, but also against the risks associated with not being transplanted at all, which entails the progression of the long-term complications of the disease. Furthermore, the impact of diabetes on manyfold aspects of life suggests that perhaps its resolution could have positive consequences on the individual’s perception of health-related quality of life. Moreover, patient reported outcomes are instrumental in evaluating treatment options and in developing a tailored approach to health care delivery.
There are two categories of patients with diabetes who could potentially benefit from solid organ pancreas transplantation: those who risk their life by not recognising when blood sugars fall too low, and those who are in need of a kidney transplant. Clinical benefits of pancreas transplantation in these two groups are different and so might be their health-related quality of life. Hence, the study aimed to stratify HRQOL results by type of transplant received.
Aims.
• The primary objective of the study was to assess long-term HRQOL after pancreas transplantation.
• The secondary aim was to establish if there were differences in various types of pancreas transplant recipients.
• Finally, the research aimed to identify which pre- and post-operative factors correlate with best/worst HRQOL, if any.Results.
A total of 98 patients who had received a pancreas transplant at Oxford Transplant Centre between February 2003 and August 2021 were enrolled. In 85% of the cases, the pancreas was transplanted along with a kidney from the same donor (simultaneous pancreas kidney transplant) or after a previous successful kidney transplant (pancreas after kidney transplant). The remaining 15% had life threatening hypoglycaemia unawareness and received a pancreas transplant alone.At the time of transplantation, the great majority of individuals had two or more chronic complications of the disease. In over one half of the cases, the post-operative course was burdened by medical or surgical complications and 22 patients were taken back to theatre for further surgery at least once. Ultimately, 5 transplant pancreatectomies were necessary, whilst no kidney graft was removed. Return to theatre occurred 2.5 times more frequently in pancreas transplant alone group.
One year after surgery 94% of patients were still insulin independent and 99% dialysis free. At the time of data collection an average of approximately 8.5 years had elapsed since transplantation and in over 90% of cases both organs were still functioning.
Hence, the information on HRQOL in this study essentially pertained to patients who had a successful, long-lasting transplant. Despite this, patient scored lower than the general population in both physical and mental HRQOL.
There was little difference between patients who received a pancreas transplant alone for brittle diabetes and a pancreas-kidney transplant. The latter had slightly higher energy levels and reported less pain. Interestingly, patients who had approached transplantation because of hypoglycaemia unawareness, had the same little level of fear of low blood sugars as those who had never lost the ability to recognise them. This can perhaps be interpreted as an indirect confirmation of the positive role of pancreatic transplantation on everyday life.We found no difference in patient reported outcomes in relation to the time from transplantation, which seems to suggest a degree of stability in HRQOL after the surgery.
A few pre-operative factors seemed to be associated with better long-term outcomes: HRQOL was significantly lower for patients who were unable to work before transplantation (employment or housework), patient who were on haemodialysis and patients who had symptoms of reduced blood supply to legs and feet.
After the surgery, the most meaningful predictor of better results was preserved renal function, although this difference was meaningful only with regards to physical aspects of HRQOL.
Conclusions.
Long term success of pancreatic transplantation is associated to stable levels of HRQOL, albeit below population standards. In other words, the procedure doesn’t restore patients to their former state, before the onset of the disease and its complications.
It is reasonable to hypothesise that the lack of further deterioration of HRQOL might reflect the positive effects of adequate metabolic control on the progression of diabetes complications.REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0145
Date of REC Opinion
18 May 2021
REC opinion
Further Information Favourable Opinion