American Hepato-Pancreato-Biliary Association (AHPBA) Pancreatic Irreversible Electroporation (IRE) Registry

Last updated: February 23, 2025
Sponsor: University of Louisville
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Pancreatitis

Pancreatic Cancer

Treatment

Registry

Clinical Study ID

NCT02674100
06-326
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to create a registry to provide insight into treatment selection and treatment outcome of pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical interventions.

The investigators seek a better understanding of the uses of ablation in the treatment of unresectable soft tissue pancreatic tumors and the limitations, concerns and complications that earlier users have.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (greater than 18 years of age) diagnosed with pancreatic cancer thatare eligible for soft tissue ablation per the treating physician.

Exclusion

Exclusion Criteria:

  • Have a cardiac pacemaker or ICD implant

  • Non-removable implants with metal parts near target lesion

  • Myocardial infarction within 3 months prior to enrollment

  • Not suitable for general endotracheal anesthesia

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Registry
Phase:
Study Start date:
January 01, 2016
Estimated Completion Date:
January 31, 2030

Study Description

Rationale:

The rationale for creating this multi-center clinical database is to optimally collect clinical and pathological data on patients with neoplasms in order to facilitate future clinical observational and outcomes-based research.

Inclusion Criteria

Patients will be considered eligible for inclusion into the database if they meet the following eligibility criteria:

Evidence/suspicion of Pancreatic neoplasm ≥ 18 years of age

Exclusion Criteria Patients will be considered ineligible for inclusion into the database if they are not able to give consent.

Inclusion of Women, Minorities and Vulnerable Subjects This protocol will include women and minority populations. Vulnerable subjects (prisoners, children, mentally disabled persons) will not be included in the study population.

Primary Study Objective(s):

To provide insight in treatment selection and treatment outcome of Pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with Pancreatic cancer requiring surgical intervention.

Secondary Study Objective(s):

To provide data on adverse events and complications related to IRE treatment.

The AHPBA will be responsible for data collection and will periodically audit the data for quality assurance purposes. The AHPBA will review outcomes reported by each participating Research Institution and if outcomes are in the lower percentile, the investigators will be offered support to analyze the reasons for the suboptimal outcomes and may seek support to improve outcomes. The participating Research Institutions will receive a certificate annually that acknowledges their participation in the Research Project.

Goal and Aims of Registry?

The Specific Aims are:

  • Gain a better understanding of the uses of ablation in the treatment of unresectable soft tissue pancreatic tumors

  • Understand the limitations, concerns, and complications that earlier users of ablation in the treatment of unresectable soft tissue pancreatic tumors have

Create a multi-institutional group that will both enroll in this registry study, but more importantly enroll in future, prospective ablation in the treatments of unresectable soft tissue pancreatic tumors studies. Any patient undergoing a soft tissue ablation may be included in this study. To confirm, you will always own your data and the registry will be used as data storage until you release your data for evaluation on a project-by-project basis.

What Patients are Eligible?

• Any patient to which the treating physician believes that ablation of their soft tissue would be feasible in the care of their disease.

Patients who can be followed and can provide outcome data to achieve the Goals and Aims of the Registry.

To participate, the only thing we need to obtain from your site is a regulatory approval letter stating that it is acceptable to collaborate with your patients de-identified data (sample data collection protocol is attached) and that you will be consenting your patients to this data collaboration (The Registry).

Case report forms/ data collection sheets are attached The data entry will be web based. All treatments must be entered-not just the first treatment. All follow up-up to 2 years or until death of patient-must be entered. Common follow up is every 3-4 months for first year and every 6 months for second year. In order to ensure data accuracy we require that, for the first 5 patients entered, the data sheets and their supporting documentation (de-identified labs, treatment dictation, etc.) be sent to us so we can make sure the data entry is correct and complete (e.g., lesion dimensions, measures of response or progression, etc.).

Connect with a study center

  • McGill University

    Montréal, Quebec
    Canada

    Active - Recruiting

  • Sanno Hospital

    Tokyo, 107-0052
    Japan

    Active - Recruiting

  • Centro Medico

    Mexico City,
    Mexico

    Active - Recruiting

  • National Taiwan University

    Taipei, 10617
    Taiwan

    Active - Recruiting

  • Freeman Hospital

    High Heaton, NE7 7DN
    United Kingdom

    Active - Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of California San Diego

    San Diego, California 92093
    United States

    Active - Recruiting

  • University of Colorado

    Denver, Colorado 80309
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33620
    United States

    Active - Recruiting

  • Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • Atlantic Health

    Millburn, New Jersey 07041
    United States

    Active - Recruiting

  • Northwell Health Cancer Institute

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Gibbs Cancer Research, Spartanburg Regional Healthcare System

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Methodist Digestive Institute

    Dallas, Texas 75203
    United States

    Active - Recruiting

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