A Prospective Observational Study of TPIAT

Active, not recruiting

Conditions: Pancreatitis, Chronic
Pancreatectomy; Hyperglycemia
Pancreatitis

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
TPIAT	TPIAT	patients undergoing total pancreatectomy with islet autotransplant.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (12): University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute
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Pittsburgh, Pennsylvania, United States
Cleveland Clinic
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Cleveland, Ohio, United States
University of Minnesota
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Minneapolis, Minnesota, United States
Cincinnati Children's Hospital Medical Center
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Cincinnati, Ohio, United States
University of California, San Francisco
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San Francisco, California, United States
Johns Hopkins Hospital
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Baltimore, Maryland, United States
The University of Chicago Medical Center
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Chicago, Illinois, United States
Baylor University Medical Center
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Dallas, Texas, United States
Dartmouth-Hitchcock Medical Center
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Lebanon, New Hampshire, United States
The Ohio State University Wexner Medical Center
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Columbus, Ohio, United States
University of Louisville
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Louisville, Kentucky, United States
Medical University of South Carolina
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Charleston, South Carolina, United States