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

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ClinicalTrials.gov Identifier: NCT02674100
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
American 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

  Show Detailed Description

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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


Contacts
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Contact: Robert Martin, MD, PhD 502-629-3355 robert.martin@louisville.edu

Locations
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United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: John Christein, MD       jchristein@uabmc.edu   
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92093
Contact: Rebekah White, MD       reqhite@ucsd.edu   
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80309
Contact: Ana Gleisner       ana.gleisner@ucdenver.edu   
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33620
Contact: Rachel Karlnoski       rkarlnos@health.usf.edu   
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Edward Kruse, MD       ekruse@gru.edu   
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Robert Martin, MD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21218
Contact: Matthew Weiss, MD       mweiss5@jhmi.edu   
United States, New Jersey
Atlantic Health Recruiting
Millburn, New Jersey, United States, 07041
Contact: Kai Bickenbach, MD       kai.beckenbach@atlantichealth.org   
United States, New York
Northwell Health Cancer Institute Recruiting
Lake Success, New York, United States, 11042
Contact: Gary Deutsch, MD       gdeutsch@northwell.edu   
United States, South Carolina
Gibbs Cancer Research, Spartanburg Regional Healthcare System Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Heather Farmer       hfarmer@gibbscc.org   
United States, Texas
Methodist Digestive Institute Recruiting
Dallas, Texas, United States, 75203
Contact: Alejandro Mejia, MD       alejandromejia@mhd.com   
Canada, Quebec
McGill University Recruiting
Montréal, Quebec, Canada
Contact: Yifan Wang       yifan.wang3@mail.mcgill.ca   
Japan
Sanno Hospital Recruiting
Tokyo, Japan, 107-0052
Contact: Morivasu Fuminori, MD       moriyasu@tokyo-med.ac.jp   
Mexico
Centro Medico Recruiting
Mexico City, Mexico
Contact: Carlos Florez-Zorrilla, MD       florezzc@gmail.com   
Taiwan
National Taiwan University Recruiting
Taipei, Taiwan, 10617
Contact: Huang Kai-Wen, MD       skywing@ntuh.gov.tw   
United Kingdom
Freeman Hospital Recruiting
High Heaton, United Kingdom, NE7 7DN
Contact: Derek Manas, MD       derek.manas@nuth.nhs.uk   
Sponsors and Collaborators
University of Louisville
American 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     History of Changes
Other Study ID Numbers: 06-326
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: September 2017
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