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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674100
Recruitment Status : Active, not recruiting
First Posted : February 4, 2016
Last Update Posted : April 13, 2021
Sponsor:
Collaborator:
The Americas Hepato-Pancreato-Biliary Association
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville

Brief 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.


Condition or disease Intervention/treatment
Pancreatic Cancer Other: Registry

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: AHPBA Pancreatic Irreversible Electroporation (IRE) Registry for Pancreatic Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 5 years ]
    Prospective collection of All Adverse Events that will be categorized as either IRE related or Non-IRE related and will be graded per CTCAE v4.0


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 5 years ]
    Capture overall survival in patients treated with IRE for their pancreatic tumors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient greater than 18 years of age that the treating physician believes that ablation of their soft tissue would be feasible in the care of their pancreatic cancer.
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674100


Locations
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United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
United States, California
University of California San Diego
San Diego, California, United States, 92093
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80309
United States, Florida
University of South Florida
Tampa, Florida, United States, 33620
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21218
United States, New Jersey
Atlantic Health
Millburn, New Jersey, United States, 07041
United States, New York
Northwell Health Cancer Institute
Lake Success, New York, United States, 11042
United States, South Carolina
Gibbs Cancer Research, Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States, 29303
United States, Texas
Methodist Digestive Institute
Dallas, Texas, United States, 75203
Canada, Quebec
McGill University
Montréal, Quebec, Canada
Japan
Sanno Hospital
Tokyo, Japan, 107-0052
Mexico
Centro Medico
Mexico City, Mexico
Taiwan
National Taiwan University
Taipei, Taiwan, 10617
United Kingdom
Freeman Hospital
High Heaton, United Kingdom, NE7 7DN
Sponsors and Collaborators
University of Louisville
The Americas Hepato-Pancreato-Biliary Association
Investigators
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Principal Investigator: Robert Martin, MD, PhD University of Louisville
Additional Information:

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Responsible Party: Robert C. Martin, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02674100    
Other Study ID Numbers: 06-326
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases