AutoTx: Extending Indication for Islet Autotransplantation in Pancreatic Surgery

Sponsor

Ospedale San Raffaele (Other)

Overall Status

Recruiting

CT.gov ID

NCT01702051

Collaborator

(none)

150

Enrollment

Location

164

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Autologous Pancreatic Islet Cell Transplantation for Improved Glycaemic Control After Pancreatectomy: Observational Study

Study Start Date :

Feb 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

Incidence of each individual postoperative complication [90 days from discharge]
death pancreatic fistula defined according to the International Study Group on Pancreatic Fistula (Bassi C et al 2005) delayed gastric emptying (DGE) defined according to the International Study Group on Pancreatic Fistula (Wente et al 2007) intra-abdominal complications medical complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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