Pancreatic Cancer, Surgery
Conditions
Brief summary
The goal of this pilot study is to evaluate and describe the immunologic and overall outcomes of subjects who undergo routine pancreatectomy with or without irreversible electroporation (IRE) for pancreatic cancer. Immunologic markers in the blood will be measured at several time points before and after surgery to determine if surgical approach is associated with different immunologic responses. Secondary outcomes will include mortality and morbidity; operative time; blood loss and transfusion requirements; and oncologic outcomes such as: margin status, lymph node harvest, disease-free survival, and overall survival. Analysis of immune response will help the investigator determine whether to expand the pilot into a larger study.
Detailed description
Subjects will have blood draws at the following timepoints: Pre-op, 1-2 days post-op, 3-5 days post-op, and 1-4 months post-op. At each timepoint, three 8.5mL ACD (yellow top) vacutainer tubes will be drawn by the Biobank and Translational Research Core (BRTC), study personnel, or hospital phlebotomists. The blood will be processed for PBMC isolation by BRTC for Dr. Weinhold's laboratory and will be viable within 8 hours of draw. These timepoints for blood draws are at the same time as usual operative care and will not require additional visits on the part of the subject. For this study we will extensively utilize several polychromatic flow cytometry (PFC) platforms to follow activation, maturation, exhaustion, and proliferation patterns within CD4+ and CD8+ subsets of T-cells. We will also utilize an intracellular cytokine staining (ICS) platform in efforts to detect anti-tumor associated antigen (TAA) responses by CD4+ and CD8+ T cells from peripheral blood mononuclear cells (PBMC) as well as lymphocytes infiltrating the patient's tumor. These assays are designed to measure antigen-driven intracellular production of IFN-γ, TNF-α, and IL-2, as well as the degranulation marker CD107. This strategy enables us to not only document individual cytokine responses, but to also assess (through Boolean gating) changes in relative polyfunctionality of the responses.
Interventions
None listed
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 suitable surgical candidate, i.e., is able to undergo general anesthesia and pancreatectomy for diagnosis of cancer * Subject is willing and able to undergo additional blood draws
Exclusion criteria
• Subject is not a suitable candidate for surgery, or surgery is unable to be completed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| immune response | preoperatively to 3 months postoperatively | proliferation of immune cells in peripheral plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgical-site infection (SSI) | 90 days | occurrence of superficial or deep infection of incision(s), by erythema/warmth/pain/swelling, need for antibiotics, positive wound cultures, purulent drainage/abscess, need to open skin incision, fascial dehiscence, etc. or documentation in the record of SSI. Organ/space infection indicated by abscess, anastomotic dehiscence, positive culture, etc. or documentation in the record of same. |
| pancreatic leak by qualitative appearance or amylase level | 90 days | Drain output or CT-guided drainage consistent with pancreatic fluid in appearance and/or amylase level, or documentation in record of same. |
| operative time | 1 day | time from start to end of operation |
| use of neoadjuvant therapy | 1 day | used = 1 |
| use of adjuvant therapy | 90 days | used = 1 |
| CA 19-9 level | 90 days | result |
| 90-day mortality | 90 days | death by 90 days |
| Non-SSI infection | 90 days | Any infection not covered by surgical-site infection, such as urinary tract infection or pneumonia. |
| margin status | 1 week | clean or unclean |
| intraoperative transfusion | 1 day | used = 1 |
| lymph node status | 1 week | positive or negative |
| overall survival | 5 years | number of months alive |
| disease-free survival | 5 years | number of months without disease |
| return to operating room | 90 days | Reoperation for exploration or repair of complication of primary procedure. Does not include wound debridement, placement of inferior vena cava filter, interventional radiology procedures, or other procedures unrelated to the initial procedure. |
Countries
United States
Outcome results
None listed