Clinical trial NCT03260387: A Prospective Observational Study of TPIAT
Official title: Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatitis, Chronic
Pancreatectomy; Hyperglycemia
Pancreatitis
Keywords: pediatric
total pancreatectomy
acute pancreatitis
chronic pancreatitis
islet transplant
islet autotransplant
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Baylor Health Care System
name: Medical University of South Carolina
name: University of Chicago
name: University of Pittsburgh Medical Center
name: Dartmouth-Hitchcock Medical Center
name: Johns Hopkins University
name: Children's Hospital Medical Center, Cincinnati
name: Ohio State University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-08-24
Enrollment: 433
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and Adults undergoing TPIAT for severe pancreatitis.

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain Reduction
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
measure: Quality of Life
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
measure: Quality of Life
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
measure: Diabetes
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
Secondary outcomes:
measure: Opioid Use
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
measure: Opioid Use
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
measure: Glycemic Control
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
measure: Insulin Dose
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
measure: Islet Graft Function
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
measure: Severe Hypoglycemia Episodes
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
measure: Pain Interference
timeFrame: Mos 6, Years 1, 2, 3, 4 after surgery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
References: