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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age

‣ ability to provide written informed consent

⁃ fasting glycaemia \<126 mg/dl without glucose-lowering medications.

Locations
Other Locations
Italy
Ospedale San Raffaele (OSR)
RECRUITING
Milan
Contact Information
Primary
Gianpaolo Balzano, MD
balzano.gianpaolo@hsr.it
0226432664
Backup
Paola Maffi, MD
maffi.paola@hsr.it
0226462575
Time Frame
Start Date: 2012-02
Estimated Completion Date: 2025-10
Participants
Target number of participants: 150
Treatments
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
Sponsors
Leads: Ospedale San Raffaele

This content was sourced from clinicaltrials.gov