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Extending Indication for Islet Autotransplantation in Pancreatic Surgery (AutoTx)

This study is currently recruiting participants.
Verified January 2016 by Piemonti Lorenzo, Scientific Institute San Raffaele
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702051
First Posted: October 5, 2012
Last Update Posted: June 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Piemonti Lorenzo, Scientific Institute San Raffaele
  Purpose
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.

Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Autologous Pancreatic Islet Cell Transplantation for Improved Glycaemic Control After Pancreatectomy: Observational Study

Further study details as provided by Piemonti Lorenzo, Scientific Institute San Raffaele:

Primary Outcome Measures:
  • Beta cell function [ Time Frame: month 1, 3, 6, 12 and every year up to death ]
    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


Secondary Outcome Measures:
  • Incidence of complications after pancreatic surgery [ Time Frame: 90 days from discharge ]
    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.


Other Outcome Measures:
  • Incidence of each individual postoperative complication [ Time Frame: 90 days from discharge ]
    1. death
    2. pancreatic fistula defined according to the International Study Group on Pancreatic Fistula (Bassi C et al 2005)
    3. delayed gastric emptying (DGE) defined according to the International Study Group on Pancreatic Fistula (Wente et al 2007)
    4. intra-abdominal complications
    5. medical complications


Biospecimen Retention:   Samples With DNA
Serum, PBMC

Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent partial or total pancreatectomy
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702051


Contacts
Contact: Gianpaolo Balzano, MD 0226432664 ext 0039 balzano.gianpaolo@hsr.it
Contact: Paola Maffi, MD 0226462575 ext 0039 maffi.paola@hsr.it

Locations
Italy
Ospedale San Raffaele (OSR) Recruiting
Milan, Italy, 20132
Contact: Gianpaolo Balzano, MD    0226432664 ext 0039    balzano.gianpaolo@hsr.it   
Principal Investigator: Lorenzo Piemonti, MD         
Principal Investigator: Gianpaolo Balzano, MD         
Principal Investigator: Paola Maffi, MD         
Sponsors and Collaborators
Ospedale San Raffaele
Investigators
Principal Investigator: Lorenzo Piemonti, MD Scientific Institute San Raffaele
Study Director: Gianpaolo Balzano, MD Scientific Institute San Raffaele