POST: A Prospective Observational Study of TPIAT

Sponsor

University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT03260387

Collaborator

Baylor Health Care System (Other), Medical University of South Carolina (Other), University of Chicago (Other), University of Pittsburgh Medical Center (Other), Dartmouth-Hitchcock Medical Center (Other), Johns Hopkins University (Other), Children's Hospital Medical Center, Cincinnati (Other), Ohio State University (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

450

Enrollment

Locations

74.9

Anticipated Duration (Months)

37.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatitis, Chronic Pancreatectomy; Hyperglycemia Pancreatitis	Procedure: 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

Study Type:

Observational

Anticipated 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 :

Jan 1, 2017

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
TPIAT patients undergoing total pancreatectomy with islet autotransplant.	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.

Arm

Intervention/Treatment

TPIAT

patients undergoing total pancreatectomy with islet autotransplant.

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.

Outcome Measures

Primary Outcome Measures

Pain Reduction [Mos 6, Years 1, 2, 3, 4 after surgery]
Visual Analog Pain Scale
Quality of Life [Mos 6, Years 1, 2, 3, 4 after surgery]
Physical Component Summary Score from SF-12
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

Secondary Outcome Measures

Opioid Use [Mos 6, Years 1, 2, 3, 4 after surgery]
proportion off opioid analgesics
Opioid Use [Mos 6, Years 1, 2, 3, 4 after surgery]
Morphine Equivalents (avg daily ME)
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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143
2	The University of Chicago Medical Center	Chicago	Illinois	United States	60637
3	University of Louisville	Louisville	Kentucky	United States	40292
4	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
5	University of Minnesota	Minneapolis	Minnesota	United States	55455
6	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
7	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
8	Cleveland Clinic	Cleveland	Ohio	United States	44195
9	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
10	University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute	Pittsburgh	Pennsylvania	United States	15213
11	Medical University of South Carolina	Charleston	South Carolina	United States	29425
12	Baylor University Medical Center	Dallas	Texas	United States	75246