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 range

18 Years – 68 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Portal vein thrombosis

Timeframe: Post operative day 4 or 5.

Clavien-Dindo classification of surgical complications

Timeframe: Within 30 days of surgery

Mixed Meal Tolerance Test

Timeframe: 1 year

Intravenous Glucose tolerance test

Timeframe: 1 year

Glucose potentiated arginine stimulation

Timeframe: 1 year

Hypoglycemic clamp

Timeframe: 1 year

Continuous glucose monitoring

Timeframe: 1 year

Hemoglobin A1c levels

Timeframe: 1 year

Trial details

NCT IDNCT03779139

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Chronic Pancreatitis trials

Plain-language summary

Who can participate

Age range

18 Years – 68 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Portal vein thrombosis

Timeframe: Post operative day 4 or 5.

Clavien-Dindo classification of surgical complications

Timeframe: Within 30 days of surgery

Mixed Meal Tolerance Test

Timeframe: 1 year

Intravenous Glucose tolerance test

Timeframe: 1 year

Glucose potentiated arginine stimulation

Timeframe: 1 year

Hypoglycemic clamp

Timeframe: 1 year

Continuous glucose monitoring

Timeframe: 1 year

Hemoglobin A1c levels

Timeframe: 1 year