Extending Indication for Islet Autotransplantation in Pancreatic Surgery

NCT01702051 | Recruiting DMC

• 1 other identifier: 43-09/02/2012
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Pancreatogenic diabetes; Autologou Islet Transplantation; Pancreas; Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of complications after pancreatic surgery

  90 days from discharge

Other Outcomes (1)

• Incidence of each individual postoperative complication

  90 days from discharge

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent partial or total pancreatectomy

You may qualify if:

• years of age
• ability to provide written informed consent
• fasting glycaemia \<126 mg/dl without glucose-lowering medications.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele (OSR)

Milan, 20132, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 24915889 BACKGROUND

• 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.

  PMID: 26695701 RESULT

• 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.

  PMID: 23751451 RESULT

• 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.

  PMID: 30549450 RESULT

• 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.

  PMID: 28358727 RESULT

• 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.

  PMID: 27327404 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum, PBMC

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lorenzo Piemonti, MD

  Scientific Institute San Raffaele

  PRINCIPAL INVESTIGATOR

• Gianpaolo Balzano, MD

  Scientific Institute San Raffaele

  STUDY DIRECTOR

Central Study Contacts

Gianpaolo Balzano, MD

CONTACT

0226432664; balzano.gianpaolo@hsr.it

Paola Maffi, MD

CONTACT

0226462575; maffi.paola@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Islet Transplantation Program

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

IT (1)