Status:
COMPLETED
Intra-Portal Alone Versus Intra- and Extra-Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis
Lead Sponsor:
University of Minnesota
Conditions:
Chronic Pancreatitis
Diabetes Mellitus
Eligibility:
All Genders
18-68 years
Phase:
NA
Brief 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 ra...
Detailed 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 wi...
Eligibility Criteria
Inclusion
- Age 18-68
- Scheduled for total pancreatectomy and IAT at U of MN. All patients who are approved for pancreatectomy and IAT at U of MN 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.
- Able to provide informed consent
Exclusion
- Pre-Existing diabetes mellitus fasting blood glucose\>115mg/dl, or hemoglobin A1c level \>6.0% because these are all evidence of inadequate beta-cello mass.
- Use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin.
- ALT or AST\>2.5 times the upper limit of normal (ULN). Bilirubin\>ULN, unless due to benign diagnosis such as Gilbert's.
- Any of the following hematologic abnormalities: server anemia (hemoglobin \<10 g/dL), thrombocytopenia (\<150/mm3), or neutropenia(\<1.0 x 109/L).
- 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.
- Current or expected use of any other immunosuppressive agent.
- Known coagulopathy, or need for anticoagulant therapy preoperatively (coumadin, enoxaparin), or any history of pulmonary embolism.
- For females, plans to become pregnant or unwillingness to use birth control for the study duration.
- Inability to comply with the study protocol.
- 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.
- Any other medical condition that , in the opinion of the investigator, may interfere wit the patient's ability to successfully and safely complete the trial.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03779139
Start Date
August 1 2019
End Date
December 31 2024
Last Update
January 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455