Last updated on November 2019

Anti-inflammatory Therapy to Improve Outcomes After TPIAT

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatitis | Chronic; Diabetes; Transplant
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age 18- 68 years. .
  2. Scheduled for total pancreatectomy and IAT at University of Minnesota (UM). All patients who are approved for pancreatectomy and IAT at UM are reviewed by a multi-disciplinary committee including surgeons, gastroenterologists specializing in pancreatic disease, a pain specialist, psychologist, and endocrinologist to confirm the diagnosis of chronic pancreatitis and candidate suitability for surgery.
  3. Able to provide informed consent

Exclusion Criteria:

  1. Pre-existing diagnosis of diabetes mellitus, fasting blood glucose >115 mg/dl, or hemoglobin A1c level >6.0% because these are all evidence of inadequate beta-cell mass.
  2. Use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, Glucagon Like Peptide (GLP)-1 agonists, dipeptidyl peptidase (DPP-4) inhibitors, or amylin.
  3. Immunoglobulin (IgA) deficiency (serum level <5 mg/dL), which has been associated with hypersensitivity to alpha-1 antitrypsin.
  4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>2.5 times the upper limit of normal (ULN). Bilirubin >ULN, unless due to benign diagnosis such as Gilbert's.
  5. Known history of human immunodeficiency virus (HIV) infection, hepatitis B (chronic), or hepatitis C (chronic).
  6. History of tuberculosis (TB) (latent or active disease), or positive TB skin test.
  7. History of symptomatic fungal lung infection.
  8. History of multiple sclerosis, transverse myelitis, Guillain Barre, or other suspected demyelinating disease, due to risk of exacerbation of these conditions with use of etanercept; or prior history of systemic lupus erythematosus
  9. Any of the following hematologic abnormalities: severe anemia (hgb <10 g/dL), thrombocytopenia (<150/mm3), or neutropenia (<1.0 x109/L).
  10. Current use or expected use of oral or injected corticosteroids, or any mediation likely to affect glucose tolerance. However, use of hydrocortisone for physiologic replacement, or use of any topical, inhaled, or intranasal glucocorticoid is permitted.
  11. Current or expected use of any other immunosuppressive agent.
  12. Known hypersensitivity to etanercept or A1AT.
  13. Any condition that is likely, in the opinion of the patient's medical providers, to necessitate use of TNF alpha therapeutically in the future (such as psoriatic arthritis).
  14. Known coagulopathy, or need for anticoagulant therapy preoperatively (coumadin, enoxaparin), or any history of pulmonary embolism.
  15. For females, plans to become pregnant or unwillingness to use birth control for the study duration.
  16. Inability to comply with the study protocol.
  17. Untreated psychiatric illness that may interfere with ability to give informed consent, or other developmental delay or neurocognitive disorder that impairs with a patient's ability to consent on their own behalf.
  18. Any other medical condition that, in the opinion of the investigator, may interfere with the patient's ability to successfully and safely complete the trial.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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