A Prospective Observational Study of TPIAT

Pancreatitis Clinical Trial

— POST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03260387
• Other study ID #: PEDS-2019-26517
• Secondary ID: R01DK109124
• Status: Active, not recruiting
• Start date: January 1, 2017
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 433
• Est. completion date: May 1, 2026
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

1. Partial pancreatectomy

2. TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)

Related Conditions & MeSH terms

• Hyperglycemia
• Pancreatectomy; Hyperglycemia
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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.

Locations

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

Sponsors (10)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Reduction	Visual Analog Pain Scale	Mos 6, Years 1, 2, 3, 4 after surgery
Primary	Quality of Life	Physical Component Summary Score from SF-12	Mos 6, Years 1, 2, 3, 4 after surgery
Primary	Quality of Life	Mental Component Summary Score from SF-12	Mos 6, Years 1, 2, 3, 4 after surgery
Primary	Diabetes	Proportion of patients insulin independent	Mos 6, Years 1, 2, 3, 4 after surgery
Secondary	Opioid Use	proportion off opioid analgesics	Mos 6, Years 1, 2, 3, 4 after surgery
Secondary	Opioid Use	Morphine Equivalents (avg daily ME)	Mos 6, Years 1, 2, 3, 4 after surgery
Secondary	Glycemic Control	HbA1c level	Mos 6, Years 1, 2, 3, 4 after surgery
Secondary	Insulin Dose	Insulin Dose (U/day)	Mos 6, Years 1, 2, 3, 4 after surgery
Secondary	Islet Graft Function	Proportion with Islet Graft Function (C-peptide + or Off Insulin)	Mos 6, Years 1, 2, 3, 4 after surgery
Secondary	Severe Hypoglycemia Episodes	Proportion of patients with Severe Hypoglycemia	Mos 6, Years 1, 2, 3, 4 after surgery
Secondary	Pain Interference	Pain interference Score (PROMIS scale)	Mos 6, Years 1, 2, 3, 4 after surgery