Study Results
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Basic Information
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UNKNOWN
110 participants
OBSERVATIONAL
2018-11-04
2022-03-31
Brief Summary
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Solid organ pancreatic transplantation restores endocrine pancreatic function. However, it is also burdened by high perioperative morbidity and mortality.
Clinical benefits and risks of this intervention have been extensively clarified, but our knowledge about quality of life gain, often mentioned among the assets of transplantation, is still limited.
This study aims to quantify the impact of all forms of Solid Organ Pancreas Transplantation on quality of life (QOL).
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Detailed Description
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There are 3.5 million people in the United Kingdom diagnosed with diabetes. Their life expectancy is significantly reduced when compared to non-diabetic population. The long standing poor metabolic control causes a cluster of complications such as metabolic instability, cardiovascular disease, nephropathy, retinopathy and neuropathy which have a major impact on the clinical and social wellbeing of these individuals.
Solid organ pancreatic transplantation restores endocrine pancreatic function, but it is still burdened by significant perioperative morbidity and mortality.
There are other less invasive transplant options we can offer to this cohort of patients. The most common are Kidney Transplant Alone (KTA) from deceased or living donor in the diabetic and uremic patients and Islets Transplant (IT) for those with hypoglycemia unawareness and preserved renal function.
Although current literature suggests that the less invasive approaches may be less effective in the long term, potentially they could resolve the most compelling clinical needs at a lower surgical risk.
There is now a general consensus that the surgical risks of pancreatic solid organ transplantation must be weighed against clinical outcomes as well as QOL gain
Aims of the study:
This study aims to quantify QOL trajectory pre- and post- pancreas transplantation and identify correlations between QOL and clinical outcomes. The data collected will be utilized to understand which forms of solid organ pancreas transplantation are associated with greater/ lesser QOL gain and to compute a cost effectiveness analysis of this intervention.
Methods:
The core of the study will be a prospective quasi-experimental design focusing on QOL outcomes for patients on the pancreas transplant waiting-list at Oxford University Transplant Centre.
Patients active on the Oxford Transplant Centre Pancreas Transplant Waiting list will be invited to take part to this study.
Participants will be requested to complete one set of validated generic and disease specific (diabetes and kidney failure where applicable) QOL questionnaires pre-transplantation and at three time points post-transplantation: 6 weeks, 6 months and 1 year. The research team will collect clinical and hospital usage data at the same time points.
At the end of data collection, statistical analysis will aim to discern overall QOL changes in terms of Quality Adjusted Life Years (QALY), but also whether different cohorts of pancreas transplant recipients (SPK, PAK, and PTA) have different QOL outcomes and in which domains of QOL they differ.
A cohort of patients who receive a PT will be matched to a cohort of patients who remain on the PT waiting-list. Matching estimators, including Propensity Score and Coarsened Exact Matching, will be used to achieve covariate balance between the synthetic treated and control groups in order to estimate the causal effect of QoL changes post-transplantation.
Cumulative hospital costs of care by treatment group will be analysed using appropriate regression methods for non-normal, continuous outcomes. Continuous QOL outcomes will be analysed using generalised linear models.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Simultaneous Pancreas Kidney Transplant Recipients
Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Simultaneous Pancreas Kidney Transplant (SPK)
Solid Organ Pancreas Transplantation with or without Kidney Transplantation
Deceased donor pancreas transplantation
Pancreas after kidney Transplant Recipients
Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Pancreas after kidney Transplant (PAK)
Solid Organ Pancreas Transplantation with or without Kidney Transplantation
Deceased donor pancreas transplantation
Pancreas Transplant Alone Recipients
Patient affected by Insulin Dependent Diabetes Mellitus with hypoglycemia unawareness undergoing Pancreas Transplant Alone (PTA)
Solid Organ Pancreas Transplantation with or without Kidney Transplantation
Deceased donor pancreas transplantation
Interventions
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Solid Organ Pancreas Transplantation with or without Kidney Transplantation
Deceased donor pancreas transplantation
Eligibility Criteria
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Inclusion Criteria
* Insulin Dependent Diabetic Patients
* Active on Pancreas Transplant Wait List
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Peter J Friend, MA, MB, FRCS, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Oxford University Hospital NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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1. Quality and Outcomes Framework (2014/15), Diabetes Prevalence Model 2016 (Public Health England) and 2012 APHO Diabetes Prevalence Model.
2. Livingstone, S.J. et al (2015) Estimated Life Expectancy in a Scottish Cohort with Type 1 Diabetes, 2008-2010. JAMA 313(1) 37-44 78 Seshasai SR on behalf of the Emerging Risk Factors Collaboration (2011) Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 3;364(9):829-41
Diabetes mellitus: a major risk factor for cardiovascular disease. A joint editorial statement by the American Diabetes Association; The National Heart, Lung, and Blood Institute; The Juvenile Diabetes Foundation International; The National Institute of Diabetes and Digestive and Kidney Diseases; and The American Heart Association. Circulation. 1999 Sep 7;100(10):1132-3. doi: 10.1161/01.cir.100.10.1132. No abstract available.
Liew G, Michaelides M, Bunce C. A comparison of the causes of blindness certifications in England and Wales in working age adults (16-64 years), 1999-2000 with 2009-2010. BMJ Open. 2014 Feb 12;4(2):e004015. doi: 10.1136/bmjopen-2013-004015.
Dean PG, Kukla A, Stegall MD, Kudva YC. Pancreas transplantation. BMJ. 2017 Apr 3;357:j1321. doi: 10.1136/bmj.j1321.
Taber DJ, Meadows HB, Pilch NA, Chavin KD, Baliga PK, Egede LE. Pre-existing diabetes significantly increases the risk of graft failure and mortality following renal transplantation. Clin Transplant. 2013 Mar-Apr;27(2):274-82. doi: 10.1111/ctr.12080. Epub 2013 Feb 6.
Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.
White SA, Shaw JA, Sutherland DE. Pancreas transplantation. Lancet. 2009 May 23;373(9677):1808-17. doi: 10.1016/S0140-6736(09)60609-7.
Other Identifiers
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18/SC/0385
Identifier Type: -
Identifier Source: org_study_id
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