Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-23 @ 7:05 PM
Study NCT ID:
NCT01702051
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2012-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extending Indication for Islet Autotransplantation in Pancreatic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, PBMC'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2012-10-03', 'studyFirstSubmitQcDate': '2012-10-04', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of each individual postoperative complication', 'timeFrame': '90 days from discharge', 'description': '1. death\n2. pancreatic fistula defined according to the International Study Group on Pancreatic Fistula (Bassi C et al 2005)\n3. delayed gastric emptying (DGE) defined according to the International Study Group on Pancreatic Fistula (Wente et al 2007)\n4. intra-abdominal complications\n5. medical complications'}], 'primaryOutcomes': [{'measure': 'Beta cell function', 'timeFrame': 'month 1, 3, 6, 12 and every year up to death', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Incidence of complications after pancreatic surgery', 'timeFrame': '90 days from discharge', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatogenic diabetes', 'Autologou Islet Transplantation', 'Pancreas', 'Pancreatectomy'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '24915889', 'type': 'BACKGROUND', '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.'}, {'pmid': '26695701', 'type': 'RESULT', '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 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': '23751451', 'type': 'RESULT', '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. Ann Surg. 2013 Aug;258(2):210-8. doi: 10.1097/SLA.0b013e31829c790d.'}, {'pmid': '30549450', 'type': 'RESULT', 'citation': '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': '28358727', 'type': 'RESULT', '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. Transplantation. 2017 Oct;101(10):2492-2500. doi: 10.1097/TP.0000000000001750.'}, {'pmid': '27327404', 'type': 'RESULT', '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) 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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent partial or total pancreatectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n\n * ability to provide written informed consent\n * fasting glycaemia \\<126 mg/dl without glucose-lowering medications.\n\nExclusion Criteria:\n\n* Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial\n* Diagnosis of intraductal papillary mucinous cancer, unless the absence of multifocal lesion is demonstrated by endoscopic US\n* 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'}, 'identificationModule': {'nctId': 'NCT01702051', 'acronym': 'AutoTx', 'briefTitle': 'Extending Indication for Islet Autotransplantation in Pancreatic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Autologous Pancreatic Islet Cell Transplantation for Improved Glycaemic Control After Pancreatectomy: Observational Study', 'orgStudyIdInfo': {'id': '43-09/02/2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'patients with chronic pancreatitis treated with total or subtotal pancreatectomy'}, {'label': '2', 'description': 'patients underwent completion pancreatectomy because of anastomotic leak after partial pancreatectomy'}, {'label': '3', 'description': 'patients underwent pancreatoduodenectomy in which pancreatic anastomosis was made impracticable by technical difficulties and/or high risk of leakage'}, {'label': '4', 'description': 'patients underwent extensive distal pancreatectomy for pancreatic lesions located at the neck'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianpaolo Balzano, MD', 'role': 'CONTACT', 'email': 'balzano.gianpaolo@hsr.it', 'phone': '0226432664', 'phoneExt': '0039'}, {'name': 'Lorenzo Piemonti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gianpaolo Balzano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paola Maffi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale San Raffaele (OSR)', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Gianpaolo Balzano, MD', 'role': 'CONTACT', 'email': 'balzano.gianpaolo@hsr.it', 'phone': '0226432664', 'phoneExt': '0039'}, {'name': 'Paola Maffi, MD', 'role': 'CONTACT', 'email': 'maffi.paola@hsr.it', 'phone': '0226462575', 'phoneExt': '0039'}], 'overallOfficials': [{'name': 'Lorenzo Piemonti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scientific Institute San Raffaele'}, {'name': 'Gianpaolo Balzano, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Scientific Institute San Raffaele'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Islet Transplantation Program', 'investigatorFullName': 'Lorenzo Piemonti', 'investigatorAffiliation': 'Scientific Institute San Raffaele'}}}}