NCT03260387

A Prospective Observational Study of TPIAT

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 433 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Pancreatitis, Chronic
• Pancreatectomy; Hyperglycemia
• Pancreatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2024-04-01
• Completion: 2026-12-31
• First posted: 2017-08-24
• Last updated: 2026-04-09

Locations

12 sites across 1 country: United States