Extending Indication for Islet Autotransplantation in Pancreatic Surgery

NCT ID: NCT01702051

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2025-10-31

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.

Conditions

Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

1

patients with chronic pancreatitis treated with total or subtotal pancreatectomy

No interventions assigned to this group

2

patients underwent completion pancreatectomy because of anastomotic leak after partial pancreatectomy

No interventions assigned to this group

3

patients underwent pancreatoduodenectomy in which pancreatic anastomosis was made impracticable by technical difficulties and/or high risk of leakage

No interventions assigned to this group

4

patients underwent extensive distal pancreatectomy for pancreatic lesions located at the neck

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Piemonti

Director Islet Transplantation Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenzo Piemonti, MD

Role: PRINCIPAL_INVESTIGATOR

Scientific Institute San Raffaele

Gianpaolo Balzano, MD

Role: STUDY_DIRECTOR

Scientific Institute San Raffaele

Locations

Ospedale San Raffaele (OSR)

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gianpaolo Balzano, MD

Role: CONTACT

balzano.gianpaolo@hsr.it

0226432664 ext. 0039

Paola Maffi, MD

Role: CONTACT

maffi.paola@hsr.it

0226462575 ext. 0039

Facility Contacts

Gianpaolo Balzano, MD

Role: primary

balzano.gianpaolo@hsr.it

0226432664 ext. 0039

References

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.

Reference Type: BACKGROUND

PMID: 24915889 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26695701 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23751451 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30549450 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28358727 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27327404 (View on PubMed)

Other Identifiers

43-09/02/2012

Identifier Type: -

Identifier Source: org_study_id