A Prospective Observational Study of TPIAT (POST)

University of Minnesota (UMN)

Status: Active, not recruiting

Conditions: Pancreatectomy; Hyperglycemia; Pancreatitis; Pancreatitis, Chronic

Treatments: Procedure: TPIAT

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03260387

R01DK109124 (U.S. NIH Grant/Contract)

PEDS-2019-26517

Details and patient eligibility

About

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

Full 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.

Enrollment: 433 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

433 participants in 1 patient group

TPIAT

Description:

patients undergoing total pancreatectomy with islet autotransplant.

Treatment:

Procedure: TPIAT