Extending Indication for Islet Autotransplantation in Pancreatic Surgery

N/ARecruitingNCT01702051

Ospedale San Raffaele150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Diabetes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: month 1, 3, 6, 12 and every year up to death

Secondary Outcomes

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.

Time frame: 90 days from discharge