Hepatic Resection for Metastatic Pancreatic Cancer

This is a small interventional pilot study that will be conducted as a single-site study at
Duke University Health System (DUHS). All subjects with pancreatic cancer and low-volume
liver metastases (< or = 3 lesions) who meet criteria for pancreatic and liver resection will
be offered the opportunity to participate. Potential subjects will be referred by the Medical
Oncology physicians at Duke if they feel like the patient would be suitable for this study.
We anticipate enrolling 2-3 subjects per year for a total of 10 evaluable subjects.

Any subject who consents to the study will proceed with primary resection, including
pancreaticoduodenectomy or distal pancreatectomy, and liver resection/ablation of the
metastases.

Screening will include a medical record review, standard of care CT scan/MRI, clinical
evaluation including physical, vitals, height weight and routine blood tests.

Preoperative data such as sex, race, age at resection, ASA class, race, body mass index
(BMI), pretreatment staging, CA 19-9 (missing in open PD), tumor size (cm), and neoadjuvant
therapy (no; yes), time to initiation and completion will also be captured.

Perioperative data like date of surgery, OR time, ASA class, intra-operative transfusion
requirements, fluid administration, EBL, operative complications (including but not limited
to infection, bleeding, need for re-operation, thrombus, pancreatic leak, bile leak, liver
failure, nutritional data like use of TPN and tube feedings, and length of stay will be
collected.

Post-operative data regarding re-admission and surveillance data for oncologic outcomes such
as re-operation, final pathology margin status, nodal status, and postoperative CA 19-9, as
well as DFS and OS, including date of death if applicable, during the provided follow up
period.

To ensure accurate and complete incorporation of medical data, a database of perioperative
outcomes will be prospectively maintained during the subject's hospital stay and for the
first 3 months following surgery. Duke University is a member of the National Surgical
Quality Improvement Program (NSQIP), with 100% participation in Hepatopancreaticobiliary
(HPB) procedures. As such, all preoperative data and 30-day outcomes are collected by a fully
trained Surgical Clinical Reviewer and are available within our electronic medical record
(EMR). NSQIP provides a robust, audited dataset that has been validated to optimize the
accuracy of data collection, substantially reducing the cost and resource requirements of
data extraction. Following this 30-day period, data will be collected at regularly scheduled
clinic visits, which typically occur weekly until 6-12 weeks post-surgery, then 3-4 months
for the first year, and every 6 months thereafter and stored in a local, REDCap database.

Subjects' medical records will be continually reviewed for surgical complications and for
overall survival (date of subject death).

Inclusion Criteria:

- Subject must be at least 18 years of age and at least the minimum Age of Majority
according to applicable State or Country Law

- Subject is a surgical candidate, (i.e., is able to undergo general anesthesia and
surgical resection for diagnosis of cancer)

- The Hepatobiliary Multidisciplinary Committee (HDMC) must approved of this
intervention.

- Insurance pre-authorization must be received.

- Subject has been informed of the study procedures and the treatment and has signed an
informed consent form

- Subjects who have undergone at least six months of chemotherapy without radiologic
progression of the tumor

- less than or equal to 3 liver lesions

Exclusion Criteria:

- Subject is not a suitable candidate for surgical intervention

- The Hepatobiliary Multidisciplinary Committee (HDMC) disapproves of this intervention.

- Insurance will not cover the procedure.

- Pregnant women

- Non-English speaking Subjects