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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 : 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

Study Description

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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Detailed 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.).

Study Design

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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

MedlinePlus related topics: Pancreatic Cancer

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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.

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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

Contacts and Locations

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

More Information

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

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