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Active, Not Recruiting

NCT Number: NCT03260387

A Prospective Observational Study of TPIAT

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatitis, Chronic Chronic Disease Digestive System Diseases Disease Attributes Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pancreatectomy; Hyperglycemia Pancreatic Diseases Pancreatitis Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TPIAT

Procedure

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.

Primary outcomes

  1. Pain Reduction

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    Visual Analog Pain Scale

  2. Quality of Life

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    Physical Component Summary Score from SF-12

  3. Quality of Life

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    Mental Component Summary Score from SF-12

  4. Diabetes

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    Proportion of patients insulin independent

Secondary outcomes

  1. Opioid Use

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    proportion off opioid analgesics

  2. Opioid Use

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    Morphine Equivalents (avg daily ME)

  3. Glycemic Control

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    HbA1c level

  4. Insulin Dose

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    Insulin Dose (U/day)

  5. Islet Graft Function

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    Proportion with Islet Graft Function (C-peptide + or Off Insulin)

  6. Severe Hypoglycemia Episodes

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    Proportion of patients with Severe Hypoglycemia

  7. Pain Interference

    Time frame: Mos 6, Years 1, 2, 3, 4 after surgery

    Pain interference Score (PROMIS scale)

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: POST

Important dates

Study start
2017
Primary completion
2024
Study completion
2026
First posted
Aug 24, 2017
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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