Partial Pancreatectomy Due to Benign Pancreatic Neoplasm
Conditions
Keywords
autologous islet transplantation, partial pancreatectomy, pancreatogenic diabetes
Brief summary
* Effects of autologous islet transplantation were compared to those of oral anti-diabetic drugs after distal pancreatectomy. * The primary interest is a insulin-secretory function after the surgery in two intervention groups.
Interventions
PROCEDUREAutologous islet transplantation
Islet was isolated from the normal part of resected pancreas with modified Ricordi method. After purification, the islets were infused into the liver through percutaneous transhepatic portal vein catheterization.
* Metformin on the diagnosis of postoperative diabetes mellitus. Starting dose of 500mg per day and dose adjustment as needed to control blood glucose. * Vildagliptin added on the insufficient glycemic control with monotherapy. Starting dose of 50mg per day and dose adjustment as needed to control blood glucose.
Sponsors
Ministry of Health & Welfare, Korea
Novartis
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass
Exclusion criteria
* Prior history of diabetes mellitus * Patients whose fasting, post-load (75g OGTT) glucose or HbA1c level meet ADA diagnostic criteria * Patients who refused to participate the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of insulin secretory function | preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. | Insulin secretion was evaluated by calculating insulinogenic index (Δ insulin30min (μIU/ml)/Δglucose30min (mmol/L) during 75g-OGTT) and homeostasis model assessment for beta cell function (HOMA-B). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of glucose tolerance | preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. | Glucose tolerance was evaluated by HbA1c (%), 1,5-anhydroglucitol (ug/ml), and area under the curve of glucose (75g OGTT, mg/dl\*min). |
| Incidence of postoperative diabetes mellitus | preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. | — |
| Changes of insulin resistance | preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. | Insulin resistance was evaluated by homeostasis model assessment for insulin resistance (HOMA-IR). |
| Adverse effects | preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. | — |
Countries
South Korea
Outcome results
None listed