Extending Indication for Islet Autotransplantation in Pancreatic Surgery

Diabetes Clinical Trial

— AutoTx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01702051
• Other study ID #: 43-09/02/2012
• Status: Recruiting
• Start date: February 2012
• Est. completion date: October 2025

Study information

• Verified date: February 2024
• Source: Ospedale San Raffaele
• Contact: Gianpaolo Balzano, MD
• Phone: 0226432664
• Email: balzano.gianpaolo[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele (OSR)	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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/malign — View Citation

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 Pancreate — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of each individual postoperative complication	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	90 days from discharge
Primary	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
Secondary	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