A Prospective Observational Study of TPIAT (POST)

University of Minnesota (UMN) logo

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

Trial contacts and locations

12

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems