AHPBA Pancreatic Irreversible Electroporation (IRE) Registry for Pancreatic Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Louisville
- Enrollment
- 500
- Locations
- 16
- Primary Endpoint
- Adverse Events
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Overall Survival(Up to 5 years)
Investigators
Robert C. Martin
Professor
University of Louisville