Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Referred for Total pancreatectomy with islet autotransplantation | Followed up for up for 15 years after TPIAT. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic islet function | AUC(0-120min) C-peptide during mixed meal tolerance test (MMTT) | Up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic islet function | Maximum C-peptide concentration during MMTT | Up to 15 years |
| Pancreatic islet function | Difference in basal and maximum C-peptide concentration during MMTT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients referred for TPIAT or who have underwent TPIAT since 2014.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prof. Eelco de Koning | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2333ZA | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) | Up to 15 years |
| Glycemic control | Standard deviation determined by FGM or CGM | Up to 15 years |
| Glycemic control | HbA1c as determined in the blood and estimated by FGM or CGM | Up to 15 years |
| Glycemic control | Insulin requirements (IU/kg/day) | Up to 15 years |
| Quality of life | assessed by MOS Short Form 36 (SF-36) questionnaire | Up to 15 years |
| Quality of life | assessed by EQ-5D questionnaire | Up to 15 years |
| Diabetes-related stress | assessed by Problem Areas in Diabetes (PAID) questionnaire | Up to 15 years |
| Exocrine pancreatic insufficiency | assessed by Pancreas Exocrine Insufficiency Questionnaire (PEI-Q) | Up to 15 years |
| Pancreas-related pain | assessed by COMPAT-SF questionnaire | Up to 15 years |
| Pancreas-related pain | assessed by Izbicki questionnaire | Up to 15 years |
| Pain perception and central sensitization | assessed by Quantitative Sensory Testing | Baseline, MOS 6 |
| Opioid usage | Morphine Milligram equivalents | Up to 15 years |
| Frequency of surgical complications | Early (<3 months) or late (>3 months) | Up to 15 years |
| Frequency of complications attributed to islet transplantation | Up to 15 years |
| Histological examination pancreas | Degree of fibrosis, acinar cell atrophy, inflammation and nesidioblastosis | After biopsy during islet isolation |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |