An observational study in Pancreatic Cancer and Surgery, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Duke University · Observational
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 33 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with pancreatic ductal adenocarcinoma who undergo surgical resection of the cancer, with or without irreversible electroporation.
Exclusion Criteria:
No intervention. Patients who undergo surgical resection of their pancreatic cancer.
immune response
proliferation of immune cells in peripheral plasma
Time frame: preoperatively to 3 months postoperatively
90-day mortality
death by 90 days
Time frame: 90 days
surgical-site infection (SSI)
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.
Time frame: 90 days
pancreatic leak by qualitative appearance or amylase level
Drain output or CT-guided drainage consistent with pancreatic fluid in appearance and/or amylase level, or documentation in record of same.
Time frame: 90 days
operative time
time from start to end of operation
Time frame: 1 day
use of neoadjuvant therapy
used = 1
Time frame: 1 day
use of adjuvant therapy
used = 1
Time frame: 90 days
CA 19-9 level
result
Time frame: 90 days
return to operating room
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.
Time frame: 90 days
Non-SSI infection
Any infection not covered by surgical-site infection, such as urinary tract infection or pneumonia.
Time frame: 90 days
margin status
clean or unclean
Time frame: 1 week
intraoperative transfusion
used = 1
Time frame: 1 day
lymph node status
positive or negative
Time frame: 1 week
overall survival
number of months alive
Time frame: 5 years
disease-free survival
number of months without disease
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Duke University