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

Sponsor: University of Louisville

NCT ID: NCT02674100

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Registry (other)
How long the study runs
Study runs about 168 months (dates as stated)
About the drug or intervention
Registry (other)
Patient visit burden
Not specified by the sponsor

In plain English

This registry, run by the University of Louisville, collects information from adults with pancreatic cancer who have a treatment called irreversible electroporation (IRE) — a way of destroying cancer tissue using electrical pulses. The registry gathers data on this treatment, which is offered when a doctor judges it suitable for the patient.

Who can take part

  • Adults over 18 years old
  • Diagnosed with pancreatic cancer
  • Able to have soft tissue ablation (a treatment that destroys tissue), in the doctor's view

Who may not be able to

  • Have a cardiac pacemaker or an implantable cardioverter defibrillator (a device fitted in the chest to control the heartbeat)
  • Have non-removable metal implants close to the area being treated
  • Have had a heart attack in the 3 months before joining
  • Not well enough for general anaesthetic with a breathing tube (being put to sleep for the procedure)

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
500
Started
2016-01
Last checked
2024-12

Plain English Summary

What is this study?

  • • Testing a new treatment for pancreatic cancer
  • • Clinical study - 500 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with pancreatic cancer

Where?

  • • High Heaton - Freeman Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.).

Pancreatic Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Adult patients (greater than 18 years of age) diagnosed with pancreatic cancer that are eligible for soft tissue...

Who cannot take part

  • ✗Have a heart 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
See the full 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

Where Is This Study? (1 UK site)

Freeman Hospital

High Heaton NE7 7DN, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Robert Martin, MD, PhD

Sponsor contact

CONTACT

502-629-3355 robert.martin@louisville.edu
Data sourced from ClinicalTrials.gov · Last verified: 2024-12