A Prospective Observational Study of TPIAT

Study Overview
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Brief Summary
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Multi-center, prospective, observational cohort study of patients undergoing total pancreatectomy with islet autotransplantation (TPIAT)

Detailed Description
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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.

Official Title
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Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST)

Conditions
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Pancreatitis, Chronic, Pancreatectomy; Hyperglycemia, Pancreatitis

Intervention / Treatment
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* Procedure: TPIAT


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TPIAT<br>patients undergoing total pancreatectomy with islet autotransplant. | Procedure: TPIAT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | Visual Analog Pain Scale | Mos 6, Years 1, 2, 3, 4 after surgery | 
| Quality of Life | Physical Component Summary Score from SF-12 | Mos 6, Years 1, 2, 3, 4 after surgery | 
| Quality of Life | Mental Component Summary Score from SF-12 | Mos 6, Years 1, 2, 3, 4 after surgery | 
| Diabetes | Proportion of patients insulin independent | Mos 6, Years 1, 2, 3, 4 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use | proportion off opioid analgesics | Mos 6, Years 1, 2, 3, 4 after surgery | 
| Opioid Use | Morphine Equivalents (avg daily ME) | Mos 6, Years 1, 2, 3, 4 after surgery | 
| Glycemic Control | HbA1c level | Mos 6, Years 1, 2, 3, 4 after surgery | 
| Insulin Dose | Insulin Dose (U/day) | Mos 6, Years 1, 2, 3, 4 after surgery | 
| Islet Graft Function | Proportion with Islet Graft Function (C-peptide + or Off Insulin) | Mos 6, Years 1, 2, 3, 4 after surgery | 
| Severe Hypoglycemia Episodes | Proportion of patients with Severe Hypoglycemia | Mos 6, Years 1, 2, 3, 4 after surgery | 
| Pain Interference | Pain interference Score (PROMIS scale) | Mos 6, Years 1, 2, 3, 4 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, total pancreatectomy, acute pancreatitis, chronic pancreatitis, islet transplant, islet autotransplant