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.
Study Type
OBSERVATIONAL
Enrollment
100
Leiden University Medical Center
Leiden, South Holland, Netherlands
Pancreatic islet function
AUC(0-120min) C-peptide during mixed meal tolerance test (MMTT)
Time frame: Up to 15 years
Pancreatic islet function
Maximum C-peptide concentration during MMTT
Time frame: Up to 15 years
Pancreatic islet function
Difference in basal and maximum C-peptide concentration during MMTT
Time frame: Up to 15 years
Glycemic control
Time below range, time in range, time above range as determined by flash glucose monitoring (FGM) or continuous glucose measurement (CGM)
Time frame: Up to 15 years
Glycemic control
Standard deviation determined by FGM or CGM
Time frame: Up to 15 years
Glycemic control
HbA1c as determined in the blood and estimated by FGM or CGM
Time frame: Up to 15 years
Glycemic control
Insulin requirements (IU/kg/day)
Time frame: Up to 15 years
Quality of life
assessed by MOS Short Form 36 (SF-36) questionnaire
Time frame: Up to 15 years
Quality of life
assessed by EQ-5D questionnaire
Time frame: Up to 15 years
Diabetes-related stress
assessed by Problem Areas in Diabetes (PAID) questionnaire
Time frame: Up to 15 years
Exocrine pancreatic insufficiency
assessed by Pancreas Exocrine Insufficiency Questionnaire (PEI-Q)
Time frame: Up to 15 years
Pancreas-related pain
assessed by COMPAT-SF questionnaire
Time frame: Up to 15 years
Pancreas-related pain
assessed by Izbicki questionnaire
Time frame: Up to 15 years
Pain perception and central sensitization
assessed by Quantitative Sensory Testing
Time frame: Baseline, MOS 6
Opioid usage
Morphine Milligram equivalents
Time frame: Up to 15 years
Frequency of surgical complications
Early (\<3 months) or late (\>3 months)
Time frame: Up to 15 years
Frequency of complications attributed to islet transplantation
Time frame: Up to 15 years
Histological examination pancreas
Degree of fibrosis, acinar cell atrophy, inflammation and nesidioblastosis
Time frame: After biopsy during islet isolation
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