Intra-Portal Alone Versus Intra- and Extra-Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis

Last updated: January 23, 2025
Sponsor: University of Minnesota
Overall Status: Completed

Phase

N/A

Condition

Diabetes Prevention

Pancreatitis

Diabetes And Hypertension

Treatment

Normal Volunteers

Intrahepatic islets alone

Intrahepatic islets and islets in the omental pouch

Clinical Study ID

NCT03779139
SURG-2017-26057
  • Ages 18-68
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Randomized pilot trial of patients (n=30) undergoing Total Pancreatectomy and Islet AutoTransplant (TPIAT). Patients with islet harvest of greater than 5000 islet equivalents/kg body weight will be randomized to receive a portion of their islets into an omental pouch. For outcomes related to islet function, a group of normal volunteers (n=15) will be studied as a comparator group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-68

  2. Scheduled for total pancreatectomy and IAT at U of MN. All patients who are approvedfor pancreatectomy and IAT at U of MN are reviewed by a multi-disciplinary committeeincluding surgeons, gastroenterologists specializing in pancreatic disease, a painspecialist psychologist, and endocrinologist to confirm the diagnosis of chronicpancreatitis and candidate suitability for surgery.

  3. Able to provide informed consent

Exclusion

Exclusion Criteria:

  1. Pre-Existing diabetes mellitus fasting blood glucose>115mg/dl, or hemoglobin A1clevel >6.0% because these are all evidence of inadequate beta-cello mass.

  2. Use of any of the following treatments in the 30 days prior to enrollment: insulin,metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4inhibitors, or amylin.

  3. ALT or AST>2.5 times the upper limit of normal (ULN). Bilirubin>ULN, unless due tobenign diagnosis such as Gilbert's.

  4. Any of the following hematologic abnormalities: server anemia (hemoglobin <10 g/dL),thrombocytopenia (<150/mm3), or neutropenia(<1.0 x 109/L).

  5. Current use or expected use of oral or injected corticosteroids, or any mediationlikely to affect glucose tolerance. However, use of hydrocortisone for physiologicreplacement, or use of any topical, inhaled or intranasal glucocorticoid ispermitted.

  6. Current or expected use of any other immunosuppressive agent.

  7. Known coagulopathy, or need for anticoagulant therapy preoperatively (coumadin,enoxaparin), or any history of pulmonary embolism.

  8. For females, plans to become pregnant or unwillingness to use birth control for thestudy duration.

  9. Inability to comply with the study protocol.

  10. Untreated psychiatric illness that may interfere with ability to give informedconsent, or other developmental delay or neurocognitive disorder that impairs with apatient's ability to consent on their own behalf.

  11. Any other medical condition that , in the opinion of the investigator, may interferewit the patient's ability to successfully and safely complete the trial.

Study Design

Total Participants: 23
Treatment Group(s): 3
Primary Treatment: Normal Volunteers
Phase:
Study Start date:
August 01, 2019
Estimated Completion Date:
December 31, 2024

Study Description

Chronic pancreatitis affects as many as 1 in every 2,500 persons and is associated with incapacitating pain, frequent hospitalization and risk of narcotic dependence. This is a debilitating disease with limited treatment options; afflicted patients are often young or middle aged adults. The health and economic costs of pancreatitis are great. Nearly $300 million is spent on emergency department visits alone in the US each year. More than 90% of patients with chronic pancreatitis have been hospitalized, half use narcotic analgesics regularly, and one-fourth are on disability. The lifetime risk of diabetes mellitus is as high as 70%. This proposal addresses needs in two broad topic areas: pancreatitis, and diabetes. The investigators propose to investigate a new technique for implanting autologous pancreatic islet cells into patients undergoing surgery for acute recurrent or chronic pancreatitis in an effort to improve long-term diabetes control.

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

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