Diabetes Mellitus, Islets of Langerhans Transplantation, Pancreatitis, Chronic
Conditions
Keywords
total pancreatectomy, autologous islet transplantation, TPIAT, beta-cell function, c-peptide
Brief summary
A total pancreatectomy with islet autotransplantation (TPIAT) can be performed for a number of benign indications, such as chronic pancreatitis. In the current standard of treatment, after non-invasive, endoscopic efforts and other surgical options to relieve the pain, a total pancreatectomy is a last resort option. The pancreas is surgically removed during this procedure. Afterwards, the patient will have diabetes mellitus that is usually difficult to control with dependency on exogenous insulin administration. In TPIAT, a total pancreatectomy is followed by islet isolation from the resected pancreas and autotransplantation of these islets into the liver by means of a transhepatic intraportal islet infusion. Depending on the number and quality of islets, TPIAT may lead to full islet function so that no anti-hyperglycemic therapy is necessary or to partial islet function necessitating anti-hyperglycemic therapy. This can be only oral agents with reasonable islet function or complex insulin regimes with poor islet function. However, even with partial Islet function, glycemic control is easier with a lower risk of hypoglycemic events and diabetes-related complications, and an overall improvement of quality of life. In this cohort, the endocrine function and glycemic variability will be monitored over time (up to 15 years). Additionally, pain scores, pain perception and central sensitization, quality of life, exocrine pancreatic insufficiency and diabetes-related stress will be monitored.
Interventions
None listed
Sponsors
Leiden University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients referred for TPIAT or TPIAT performed since 2014 * Active and/or passive understanding of the Dutch language * Willingness to wear a FGM or CGM device at least in the 2 weeks prior to TPIAT, first 3 months after TPIAT and for 2 weeks before yearly clinical visits.
Exclusion criteria
* Known malignancies of the pancreas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic islet function | Up to 15 years | AUC(0-120min) C-peptide during mixed meal tolerance test (MMTT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | Up to 15 years | Time below range, time in range, time above range as determined by flash glucose monitoring (FGM) or continuous glucose measurement (CGM) |
| Quality of life | Up to 15 years | assessed by MOS Short Form 36 (SF-36) questionnaire |
| Diabetes-related stress | Up to 15 years | assessed by Problem Areas in Diabetes (PAID) questionnaire |
| Exocrine pancreatic insufficiency | Up to 15 years | assessed by Pancreas Exocrine Insufficiency Questionnaire (PEI-Q) |
| Pancreas-related pain | Up to 15 years | assessed by COMPAT-SF questionnaire |
| Pancreatic islet function | Up to 15 years | Maximum C-peptide concentration during MMTT |
| Opioid usage | Up to 15 years | Morphine Milligram equivalents |
| Frequency of surgical complications | Up to 15 years | Early (\<3 months) or late (\>3 months) |
| Frequency of complications attributed to islet transplantation | Up to 15 years | — |
| Histological examination pancreas | After biopsy during islet isolation | Degree of fibrosis, acinar cell atrophy, inflammation and nesidioblastosis |
| Pain perception and central sensitization | Baseline, MOS 6 | assessed by Quantitative Sensory Testing |
Countries
Netherlands
Outcome results
None listed