NCT03260387

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2017Dec 2026

Study Start

First participant enrolled

January 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

7.3 years

First QC Date

August 21, 2017

Last Update Submit

April 3, 2026

Conditions

PancreatitisPancreatitis, ChronicPancreatectomy; Hyperglycemia

Keywords

pediatrictotal pancreatectomyacute pancreatitischronic pancreatitisislet transplantislet autotransplant

Outcome Measures

Primary Outcomes (4)

  • Pain Reduction

    Visual Analog Pain Scale

    Mos 6, Years 1, 2, 3, 4 after surgery

  • Quality of Life

    Physical Component Summary Score from SF-12

    Mos 6, Years 1, 2, 3, 4 after surgery

  • Quality of Life

    Mental Component Summary Score from SF-12

    Mos 6, Years 1, 2, 3, 4 after surgery

  • Diabetes

    Proportion of patients insulin independent

    Mos 6, Years 1, 2, 3, 4 after surgery

Secondary Outcomes (7)

  • Opioid Use

    Mos 6, Years 1, 2, 3, 4 after surgery

  • Opioid Use

    Mos 6, Years 1, 2, 3, 4 after surgery

  • Glycemic Control

    Mos 6, Years 1, 2, 3, 4 after surgery

  • Insulin Dose

    Mos 6, Years 1, 2, 3, 4 after surgery

  • Islet Graft Function

    Mos 6, Years 1, 2, 3, 4 after surgery

  • +2 more secondary outcomes

Study Arms (1)

TPIAT

patients undergoing total pancreatectomy with islet autotransplant.

Procedure: TPIAT

Interventions

TPIATPROCEDURE

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.

TPIAT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children and Adults undergoing TPIAT for severe pancreatitis.

You may qualify if:

  • \. Any patient with chronic or recurrent acute pancreatitis undergoing total or completion pancreatectomy with islet autotransplantation at a participating center.

You may not qualify if:

  • Partial pancreatectomy
  • TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Optional (opt in) biorepository samples: 1. Blood (plasma, serum, buffy coat) 2. Urine 3. Saliva 4. Pancreas biopsy at time of surgery

MeSH Terms

Conditions

Pancreatitis, ChronicHyperglycemiaPancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 24, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(12)