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

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 |

- 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
- Overall Survival [ Time Frame: Up to 5 years ]Capture overall survival in patients treated with IRE for their pancreatic tumors

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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
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 |
Principal Investigator: | Robert Martin, MD, PhD | University of Louisville |
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 |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |