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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

Tracking Information
First Submitted Date January 29, 2016
First Posted Date February 4, 2016
Last Update Posted Date April 13, 2021
Study Start Date January 2016
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2017)
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
Original Primary Outcome Measures
 (submitted: February 1, 2016)
  • Adverse Events [ Time Frame: Up to 15 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
  • Patient Selection [ Time Frame: Up to 15 Years ]
    To prospectively capture the type of patient (based on Tumor Type, Size, Patient Performance Status, Stage, and Location)
Change History
Current Secondary Outcome Measures
 (submitted: September 29, 2017)
Overall Survival [ Time Frame: Up to 5 years ]
Capture overall survival in patients treated with IRE for their pancreatic tumors
Original Secondary Outcome Measures
 (submitted: February 1, 2016)
Overall Survival [ Time Frame: Up to 15 years ]
Capture overall survival in patients treated with IRE for their pancreatic tumors
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title American Hepato-Pancreato-Biliary Association (AHPBA) Pancreatic Irreversible Electroporation (IRE) Registry
Official Title AHPBA Pancreatic Irreversible Electroporation (IRE) Registry for Pancreatic Cancer
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.

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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.
Condition Pancreatic Cancer
Intervention Other: Registry
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 29, 2017)
500
Original Estimated Enrollment
 (submitted: February 1, 2016)
1000
Estimated Study Completion Date January 2030
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Japan,   Mexico,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02674100
Other Study ID Numbers 06-326
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Robert C. Martin, University of Louisville
Study Sponsor University of Louisville
Collaborators The Americas Hepato-Pancreato-Biliary Association
Investigators
Principal Investigator: Robert Martin, MD, PhD University of Louisville
PRS Account University of Louisville
Verification Date March 2020