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

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.).

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