<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01702051</url>
  </required_header>
  <id_info>
    <org_study_id>43-09/02/2012</org_study_id>
    <nct_id>NCT01702051</nct_id>
  </id_info>
  <brief_title>Extending Indication for Islet Autotransplantation in Pancreatic Surgery</brief_title>
  <acronym>AutoTx</acronym>
  <official_title>Autologous Pancreatic Islet Cell Transplantation for Improved Glycaemic Control After Pancreatectomy: Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale San Raffaele</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Islet autotransplantation (IAT) is a therapeutic approach used to prevent pancreatogenic&#xD;
      diabetes or to reduce the severity of diabetes after a major pancreatectomy. Total&#xD;
      pancreatectomy with IAT is being used almost exclusively for treatment of chronic&#xD;
      pancreatitis. More recently, indications other than chronic pancreatitis have been reported&#xD;
      including IAT after extended pancreatectomy performed for the resection of benign tumors of&#xD;
      the mid-segment of the pancreas or IAT after total pancreatectomy for severe abdominal trauma&#xD;
      In this study, we study our experience with IAT for the treatment of a broader population of&#xD;
      patients undergoing pancreatic surgery including subjects with technically unfeasible or high&#xD;
      risk pancreatic anastomosis during partial pancreatectomy and subjects undergoing completion&#xD;
      pancreatectomy because of anastomosis leakage after pancreatoduodenectomy for nonmalignant or&#xD;
      malignant diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Beta cell function</measure>
    <time_frame>month 1, 3, 6, 12 and every year up to death</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of complications after pancreatic surgery</measure>
    <time_frame>90 days from discharge</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of each individual postoperative complication</measure>
    <time_frame>90 days from discharge</time_frame>
    <description>death&#xD;
pancreatic fistula defined according to the International Study Group on Pancreatic Fistula (Bassi C et al 2005)&#xD;
delayed gastric emptying (DGE) defined according to the International Study Group on Pancreatic Fistula (Wente et al 2007)&#xD;
intra-abdominal complications&#xD;
medical complications</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>patients with chronic pancreatitis treated with total or subtotal pancreatectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>patients underwent completion pancreatectomy because of anastomotic leak after partial pancreatectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <description>patients underwent pancreatoduodenectomy in which pancreatic anastomosis was made impracticable by technical difficulties and/or high risk of leakage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <description>patients underwent extensive distal pancreatectomy for pancreatic lesions located at the neck</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, PBMC&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent partial or total pancreatectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
               -  ability to provide written informed consent&#xD;
&#xD;
               -  fasting glycaemia &lt;126 mg/dl without glucose-lowering medications.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical condition that, in the opinion of the investigator, will interfere with&#xD;
             the safe completion of the trial&#xD;
&#xD;
          -  Diagnosis of intraductal papillary mucinous cancer, unless the absence of multifocal&#xD;
             lesion is demonstrated by endoscopic US&#xD;
&#xD;
          -  Presence of multifocal or residual disease at the pancreatic margin. If a malignat&#xD;
             disease is the reason for the surgery, 1 cm of the pancreatic remnant in proximity to&#xD;
             the pancreatic margin will be resected and sent for immediate pathologic analysis to&#xD;
             confirm margin negativity and to rule out multifocal tumor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lorenzo Piemonti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scientific Institute San Raffaele</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gianpaolo Balzano, MD</last_name>
    <role>Study Director</role>
    <affiliation>Scientific Institute San Raffaele</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gianpaolo Balzano, MD</last_name>
    <phone>0226432664</phone>
    <phone_ext>0039</phone_ext>
    <email>balzano.gianpaolo@hsr.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Paola Maffi, MD</last_name>
    <phone>0226462575</phone>
    <phone_ext>0039</phone_ext>
    <email>maffi.paola@hsr.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ospedale San Raffaele (OSR)</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianpaolo Balzano, MD</last_name>
      <phone>0226432664</phone>
      <phone_ext>0039</phone_ext>
      <email>balzano.gianpaolo@hsr.it</email>
    </contact>
    <investigator>
      <last_name>Lorenzo Piemonti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gianpaolo Balzano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paola Maffi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>24915889</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>26695701</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>23751451</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>30549450</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>28358727</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>27327404</PMID>
  </results_reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>December 1, 2022</last_update_submitted>
  <last_update_submitted_qc>December 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Scientific Institute San Raffaele</investigator_affiliation>
    <investigator_full_name>Lorenzo Piemonti</investigator_full_name>
    <investigator_title>Director Islet Transplantation Program</investigator_title>
  </responsible_party>
  <keyword>Pancreatogenic diabetes</keyword>
  <keyword>Autologou Islet Transplantation</keyword>
  <keyword>Pancreas</keyword>
  <keyword>Pancreatectomy</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702051
org study id: 43-09/02/2012
nct id: NCT01702051
lead sponsor: 
has dmc: Yes
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.
observational model: Cohort
time perspective: Retrospective
measure: Beta cell function
time frame: 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
measure: Incidence of complications after pancreatic surgery
time frame: 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.
measure: Incidence of each individual postoperative complication
time frame: 90 days from discharge
description: 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
arm group label: 1
description: patients with chronic pancreatitis treated with total or subtotal pancreatectomy
arm group label: 2
description: patients underwent completion pancreatectomy because of anastomotic leak after partial pancreatectomy
arm group label: 3
description: patients underwent pancreatoduodenectomy in which pancreatic anastomosis was made impracticable by technical difficulties and/or high risk of leakage
arm group label: 4
description: patients underwent extensive distal pancreatectomy for pancreatic lesions located at the neck
Serum, PBMC
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lorenzo Piemonti, MD
role: Principal Investigator
affiliation: Scientific Institute San Raffaele
last name: Gianpaolo Balzano, MD
role: Study Director
affiliation: Scientific Institute San Raffaele
last name: Gianpaolo Balzano, MD
phone: 0226432664
phone ext: 0039
email: balzano.gianpaolo@hsr.it
last name: Paola Maffi, MD
phone: 0226462575
phone ext: 0039
email: maffi.paola@hsr.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Italy
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: 24915889
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: 26695701
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: 23751451
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: 30549450
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: 28358727
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.
PMID: 27327404
responsible party type: Principal Investigator
investigator affiliation: Scientific Institute San Raffaele
investigator full name: Lorenzo Piemonti
investigator title: Director Islet Transplantation Program