A Prospective Observational Study of TPIAT

a study on Pancreatitis

Summary

at San Francisco, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

Pancreatitis, ChronicPancreatectomy; HyperglycemiaPancreatitispediatrictotal pancreatectomyacute pancreatitischronic pancreatitisislet transplantislet autotransplantHyperglycemiaTPIAT

Eligibility

You can join if…

  1. Any patient with chronic or recurrent acute pancreatitis undergoing total or completion pancreatectomy with islet autotransplantation at a participating center.

You CAN'T join if...

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

Locations

  • University of California, San Francisco accepting new patients
    San FranciscoCalifornia94143United States
  • Baylor University Medical Center accepting new patients
    DallasTexas75246United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Minnesota - Clinical and Translational Science Institute
ID
NCT03260387
Study Type
Observational
Last Updated