Intra-Portal Alone Versus Intra- and Extra-Portal Transplantation of Pancreatic Islets After Tota… (NCT03779139) | Clinical Trial Compass
CompletedNot Applicable
Intra-Portal Alone Versus Intra- and Extra-Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis
United States23 participantsStarted 2019-08-01
Plain-language 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.
Who can participate
Age range18 Years – 68 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
Portal vein thrombosis
Timeframe: Post operative day 4 or 5.
2
Clavien-Dindo classification of surgical complications