Trial record 1 of 1 for:
ahpba, ire
American Hepato-Pancreato-Biliary Association (AHPBA) Pancreatic Irreversible Electroporation (IRE) Registry
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| ClinicalTrials.gov Identifier: NCT02674100 |
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Recruitment Status :
Recruiting
First Posted : February 4, 2016
Last Update Posted : April 19, 2018
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Sponsor:
University of Louisville
Collaborator:
American Hepato-Pancreato-Biliary Association
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville
- Study Details
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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
| 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
MedlinePlus related topics:
Pancreatic Cancer
Primary Outcome Measures :
- 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 :
- 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
| Contact: Robert Martin, MD, PhD | 502-629-3355 | robert.martin@louisville.edu |
Locations
| 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
| Principal Investigator: | Robert Martin, MD, PhD | University of Louisville |
Additional Information:
| 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:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |