A Prospective Observational Study of TPIAT (POST)

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatitis; Pancreatectomy; Hyperglycemia; Pancreatitis, Chronic
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 433

Contacts and Locations

• Study Contact: Name: Melena Bellin, MD; Phone Number: 612-625-4686; Email: bell0130@umn.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40292
      • University of Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children and Adults undergoing TPIAT for severe pancreatitis.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pediatric; acute pancreatitis; chronic pancreatitis; total pancreatectomy; islet transplant; islet autotransplant
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Pancreatic Diseases; Chronic Disease; Hyperglycemia; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: PEDS-2019-26517; R01DK109124 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No