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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | patients with chronic pancreatitis treated with total or subtotal pancreatectomy | ||
| 2 | patients underwent completion pancreatectomy because of anastomotic leak after partial pancreatectomy | ||
| 3 | patients underwent pancreatoduodenectomy in which pancreatic anastomosis was made impracticable by technical difficulties and/or high risk of leakage | ||
| 4 | patients underwent extensive distal pancreatectomy for pancreatic lesions located at the neck |
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| Measure | Description | Time Frame |
|---|---|---|
| Beta cell function | 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 | month 1, 3, 6, 12 and every year up to death |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications after pancreatic surgery | 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. | 90 days from discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of each individual postoperative complication |
| 90 days from discharge |
Inclusion Criteria:
18 years of age
Exclusion Criteria:
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Patients who underwent partial or total pancreatectomy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianpaolo Balzano, MD | Contact | 0226432664 | 0039 | balzano.gianpaolo@hsr.it |
| Paola Maffi, MD | Contact | 0226462575 | 0039 | maffi.paola@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Piemonti, MD | Scientific Institute San Raffaele | Principal Investigator |
| Gianpaolo Balzano, MD | Scientific Institute San Raffaele | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele (OSR) | Recruiting | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24915889 | Background | Balzano G, Piemonti L. Autologous islet transplantation in patients requiring pancreatectomy for neoplasm. Curr Diab Rep. 2014 Aug;14(8):512. doi: 10.1007/s11892-014-0512-2. | |
| 26695701 | Result | Balzano G, Maffi P, Nano R, Mercalli A, Melzi R, Aleotti F, Zerbi A, De Cobelli F, Gavazzi F, Magistretti P, Scavini M, Peccatori J, Secchi A, Ciceri F, Del Maschio A, Falconi M, Piemonti L. Autologous Islet Transplantation in Patients Requiring Pancreatectomy: A Broader Spectrum of Indications Beyond Chronic Pancreatitis. Am J Transplant. 2016 Jun;16(6):1812-26. doi: 10.1111/ajt.13656. Epub 2016 Mar 1. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Serum, PBMC
| 23751451 | Result | Balzano G, Maffi P, Nano R, Zerbi A, Venturini M, Melzi R, Mercalli A, Magistretti P, Scavini M, Castoldi R, Carvello M, Braga M, Del Maschio A, Secchi A, Staudacher C, Piemonti L. Extending indications for islet autotransplantation in pancreatic surgery. Ann Surg. 2013 Aug;258(2):210-8. doi: 10.1097/SLA.0b013e31829c790d. |
| 30549450 | Result | Balzano G, Maffi P, Nano R, Mercalli A, Melzi R, Aleotti F, De Cobelli F, Magistretti P, Scavini M, Secchi A, Falconi M, Piemonti L. Diabetes-free survival after extended distal pancreatectomy and islet auto transplantation for benign or borderline/malignant lesions of the pancreas. Am J Transplant. 2019 Mar;19(3):920-928. doi: 10.1111/ajt.15219. Epub 2019 Jan 23. |
| 28358727 | Result | Balzano G, Nano R, Maffi P, Mercalli A, Melzi R, Aleotti F, Gavazzi F, Berra C, De Cobelli F, Venturini M, Magistretti P, Scavini M, Capretti G, Del Maschio A, Secchi A, Zerbi A, Falconi M, Piemonti L. Salvage Islet Auto Transplantation After Relaparatomy. Transplantation. 2017 Oct;101(10):2492-2500. doi: 10.1097/TP.0000000000001750. |
| 27327404 | Result | Venturini M, Sallemi C, Colantoni C, Agostini G, Balzano G, Esposito A, Secchi A, De Cobelli F, Falconi M, Piemonti L, Maffi P, Del Maschio A. Single-centre experience of extending indications for percutaneous intraportal islet autotransplantation (PIPIAT) after pancreatic surgery to prevent diabetes: feasibility, radiological aspects, complications and clinical outcome. Br J Radiol. 2016 Aug;89(1064):20160246. doi: 10.1259/bjr.20160246. Epub 2016 Jun 21. |