Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-04 @ 3:50 PM
Study NCT ID:
NCT03921593
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Pancreas Transplantation
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
Prospective Longitudinal Observational Study on Insulin Dependent Diabetic Patients Undergoing Any Form of Solid Organ Pancreas Transplantation Aimed to Clarify Quality of Life Changes After Pancreas Transplantation
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Quality of Life for individuals with Insulin Dependent Diabetes Mellitus (IDDM) can be severely impaired by acute and chronic complications of the disease.
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).
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).
Detailed Description:
Rationale of the study:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: