Diabetes
Conditions
Keywords
Pancreatogenic diabetes, Autologou Islet Transplantation, Pancreas, Pancreatectomy
Brief summary
Islet autotransplantation (IAT) is a therapeutic approach used to prevent pancreatogenic diabetes or to reduce the severity of diabetes after a major pancreatectomy. Total pancreatectomy with IAT is being used almost exclusively for treatment of chronic pancreatitis. More recently, indications other than chronic pancreatitis have been reported including IAT after extended pancreatectomy performed for the resection of benign tumors of the mid-segment of the pancreas or IAT after total pancreatectomy for severe abdominal trauma In this study, we study our experience with IAT for the treatment of a broader population of patients undergoing pancreatic surgery including subjects with technically unfeasible or high risk pancreatic anastomosis during partial pancreatectomy and subjects undergoing completion pancreatectomy because of anastomosis leakage after pancreatoduodenectomy for nonmalignant or malignant diseases.
Interventions
None listed
Sponsors
Ospedale San Raffaele
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age * ability to provide written informed consent * fasting glycaemia \<126 mg/dl without glucose-lowering medications.
Exclusion criteria
* Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial * Diagnosis of intraductal papillary mucinous cancer, unless the absence of multifocal lesion is demonstrated by endoscopic US * Presence of multifocal or residual disease at the pancreatic margin. If a malignat disease is the reason for the surgery, 1 cm of the pancreatic remnant in proximity to the pancreatic margin will be resected and sent for immediate pathologic analysis to confirm margin negativity and to rule out multifocal tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beta cell function | month 1, 3, 6, 12 and every year up to death | Beta-cell function will be assessed by fasting C peptide, HbA1c,glycaemia, change in average daily insulin requirements, basal (fasting) and -10 to 120 min time course of glucose, C-peptide and insulin derived from the arginine test, beta-score and Transplant Estimated Function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications after pancreatic surgery | 90 days from discharge | Complications will be defined and graded according to the Novel Grading System classification ( DeOliveira et al 2006). A special emphasis is given to life-threatening and permanently disabling complications. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of each individual postoperative complication | 90 days from discharge | 1. death 2. pancreatic fistula defined according to the International Study Group on Pancreatic Fistula (Bassi C et al 2005) 3. delayed gastric emptying (DGE) defined according to the International Study Group on Pancreatic Fistula (Wente et al 2007) 4. intra-abdominal complications 5. medical complications |
Countries
Italy
Contacts
Primary ContactGianpaolo Balzano, MD
Backup ContactPaola Maffi, MD
Outcome results
None listed