Pancreatitis, ChronicPOSTNCT03260387
A Prospective Observational Study of TPIAT
An observational study of Pancreatitis, Chronic and Pancreatectomy; Hyperglycemia, run by University of Minnesota at 12 sites in United States.
Trial summary
Multi-center, prospective, observational cohort study of patients undergoing total pancreatectomy with islet autotransplantation (TPIAT) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatitis, Chronic, Pancreatectomy; Hyperglycemia, Pancreatitis
- What is being tested?
- TPIAT
- Type of treatment
- Surgery or procedure
- How many people
- 433 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Jan 2017to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and Adults undergoing TPIAT for severe pancreatitis.
Who may be able to join
- 1. Any patient with chronic or recurrent acute pancreatitis undergoing total or completion pancreatectomy with islet autotransplantation at a participating center.
Who cannot join
- Partial pancreatectomy
- TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Medical University of South Carolina
Charleston, South Carolina, 29425
The University of Chicago Medical Center
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor University Medical Center
Dallas, Texas, 75246
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Louisville
Louisville, Kentucky, 40292
University of Minnesota
Minneapolis, Minnesota, 55455
University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute
Pittsburgh, Pennsylvania, 15213
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST)
Multi-center, prospective, observational cohort study of patients undergoing total pancreatectomy with islet autotransplantation (TPIAT)
Read the detailed description
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.
- Being tested
- TPIAT
- Keywords
- pediatric, total pancreatectomy, acute pancreatitis, chronic pancreatitis, islet transplant, islet autotransplant
- Medical subject headings
- Pancreatitis, Chronic, Hyperglycemia, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPIATProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TPIAT | patients undergoing total pancreatectomy with islet autotransplant. Receives: Procedure: TPIAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Visual Analog Pain Scale
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Quality of Life
Physical Component Summary Score from SF-12
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Quality of Life
Mental Component Summary Score from SF-12
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Diabetes
Proportion of patients insulin independent
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Secondary outcomes (7)
Opioid Use
proportion off opioid analgesics
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Opioid Use
Morphine Equivalents (avg daily ME)
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Glycemic Control
HbA1c level
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Insulin Dose
Insulin Dose (U/day)
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Islet Graft Function
Proportion with Islet Graft Function (C-peptide + or Off Insulin)
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Severe Hypoglycemia Episodes
Proportion of patients with Severe Hypoglycemia
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Pain Interference
Pain interference Score (PROMIS scale)
Measured: Mos 6, Years 1, 2, 3, 4 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Jan 2017
- Primary completion1 Apr 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor Health Care System, Medical University of South Carolina, University of Chicago, University of Pittsburgh Medical Center, Dartmouth-Hitchcock Medical Center, Johns Hopkins University, Children's Hospital Medical Center, Cincinnati, Ohio State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260387
- Sponsor's protocol ID
- PEDS-2019-26517
- Other IDs
- R01DK109124
- Acronym
- POST
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2017
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST)
- ClinicalTrials.gov ID
- NCT03260387
- Acronym / sponsor ID
- POST / PEDS-2019-26517
- Keywords
- pediatric, total pancreatectomy, acute pancreatitis, chronic pancreatitis, islet transplant, islet autotransplant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 433 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Baylor Health Care System, Medical University of South Carolina, University of Chicago, University of Pittsburgh Medical Center, Dartmouth-Hitchcock Medical Center, Johns Hopkins University, Children's Hospital Medical Center, Cincinnati, Ohio State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, prospective, observational cohort study of patients undergoing total pancreatectomy with islet autotransplantation (TPIAT)
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPIAT | – | Procedure: TPIATpatients undergoing total pancreatectomy with islet autotransplant. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and Adults undergoing TPIAT for severe pancreatitis.
Key inclusion criteria (1 listed)
- 1. Any patient with chronic or recurrent acute pancreatitis undergoing total or completion pancreatectomy with islet autotransplantation at a participating center.
Key exclusion criteria (2 listed)
- Partial pancreatectomy
- TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPIATThe 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. | Procedure or surgery | TPIAT |
Primary outcome
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
7 secondary outcomes
Opioid Use
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Opioid Use
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Glycemic Control
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Insulin Dose
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Islet Graft Function
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Severe Hypoglycemia Episodes
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Pain Interference
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, Chronic and Pancreatectomy; Hyperglycemia, run by University of Minnesota at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction (time frame: Mos 6, Years 1, 2, 3, 4 after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.