A Prospective Observational Study of TPIAT (POST)
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ClinicalTrials.gov Identifier: NCT03260387 |
Recruitment Status :
Recruiting
First Posted : August 24, 2017
Last Update Posted : September 30, 2022
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Condition or disease | Intervention/treatment |
---|---|
Pancreatitis, Chronic Pancreatectomy; Hyperglycemia Pancreatitis | Procedure: TPIAT |
Patients who are undergoing TPIAT at one of the participating center are invited to participate in this observational study, with 450 participants anticipated. The aims of the study are:
Aim 1: To determine (1a) whether patient and disease characteristics are associated with favorable pain and health-related quality-of-life outcomes (HRQOL) after TPIAT; (1b) the optimal timing of the TPIAT intervention to resolve pain and improve HRQOL; and (1c) in a subset of patients, the impact of central sensitization on pain resolution.
Aim 2: To determine (2a) whether patient and disease characteristics are associated with favorable glycemic outcomes from the IAT procedure; and (2b) the optimal timing of TPIAT to obtain post-surgical insulin independence.
Aim 3: To determine the cost-effectiveness of TPIAT.
Study Type : | Observational |
Estimated Enrollment : | 450 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST) |
Actual Study Start Date : | January 1, 2017 |
Estimated Primary Completion Date : | April 1, 2023 |
Estimated Study Completion Date : | April 1, 2023 |

Group/Cohort | Intervention/treatment |
---|---|
TPIAT
patients undergoing total pancreatectomy with islet autotransplant.
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Procedure: TPIAT
The entire pancreas is removed to treat the pain of chronic pancreatitis, and the islets are infused back into the patient to reduce diabetes risk after surgery. |
- Pain Reduction [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]Visual Analog Pain Scale
- Quality of Life [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]Physical Component Summary Score from SF-12
- Quality of Life [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]Mental Component Summary Score from SF-12
- Diabetes [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]Proportion of patients insulin independent
- Opioid Use [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]proportion off opioid analgesics
- Opioid Use [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]Morphine Equivalents (avg daily ME)
- Glycemic Control [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]HbA1c level
- Insulin Dose [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]Insulin Dose (U/day)
- Islet Graft Function [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]Proportion with Islet Graft Function (C-peptide + or Off Insulin)
- Severe Hypoglycemia Episodes [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]Proportion of patients with Severe Hypoglycemia
- Pain Interference [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]Pain interference Score (PROMIS scale)
Biospecimen Retention: Samples With DNA
Optional (opt in) biorepository samples:
- Blood (plasma, serum, buffy coat)
- Urine
- Saliva
- Pancreas biopsy at time of surgery

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
1. Any patient with chronic or recurrent acute pancreatitis undergoing total or completion pancreatectomy with islet autotransplantation at a participating center.
Exclusion Criteria:
- Partial pancreatectomy
- TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260387
Contact: Melena Bellin, MD | 612-625-4686 | bell0130@umn.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Joanne Kwan 415-476-2574 Joanne.Kwan@ucsf.edu | |
United States, Illinois | |
The University of Chicago Medical Center | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Lindsay Basto 773-702-2504 Lindsay.basto@uchospitals.edu | |
United States, Kentucky | |
University of Louisville | Recruiting |
Louisville, Kentucky, United States, 40292 | |
Contact: Mechelle Kaufman 502-852-7507 mechelle.stoner@louisville.edu | |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Mahya Faghih 443-761-9157 mfaghih2@jhu.edu | |
United States, Minnesota | |
University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Peggy Ptacek 612-626-5905 vorwa001@umn.edu | |
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | Recruiting |
Lebanon, New Hampshire, United States, 03756 | |
Contact: Penny Doughty 603-653-6048 Penny.J.Doughty@hitchcock.org | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Jyoti Patel 513-636-0091 jyoti.patel@cchmc.org | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Amy Orasko 216-444-3267 OraskoA@ccf.org | |
The Ohio State University Wexner Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Jill Buss 614-292-9309 Jill.Buss@osumc.edu | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Rita Johnson 412-383-8616 johnsonr1@upmc.edu | |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Jason Hirsch 843-792-8824 hirschj@musc.edu | |
United States, Texas | |
Baylor University Medical Center | Recruiting |
Dallas, Texas, United States, 75246 | |
Contact: Rehma Shabbir 214-820-1768 rehma.shabbir@bswhealth.org |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT03260387 |
Other Study ID Numbers: |
PEDS-2019-26517 R01DK109124 ( U.S. NIH Grant/Contract ) |
First Posted: | August 24, 2017 Key Record Dates |
Last Update Posted: | September 30, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
pediatric total pancreatectomy acute pancreatitis |
chronic pancreatitis islet transplant islet autotransplant |
Pancreatitis Pancreatitis, Chronic Hyperglycemia Pancreatic Diseases |
Digestive System Diseases Glucose Metabolism Disorders Metabolic Diseases |