Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Local recurrence at the site of resection
Study Overview
Brief Summary
This study is being done to investigate another way of evaluating margin status after pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional method of surgical pathology
Detailed Description
PRIMARY OBJECTIVES:
I. To compare margin status on final pathology with margin status from cytopathologic evaluation.
OUTLINE:
Patients undergo cytopathologic sample collection during pancreatic resection during which slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along the superior mesenteric artery, and finally against the tumor itself.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients undergoing pancreatic resection for a presumed, although not necessarily biopsy-proven pancreatic malignancy,
- •ages 18 years to 80 years old
Exclusion Criteria
- •Pregnant women
Outcomes
Primary Outcomes
Local recurrence at the site of resection
Time Frame: up to 2 years
Will be evaluated in a Cox proportion hazards regression model. The prognostic ability of the histological reporting of the specimen margin as well as the cytopathological reporting of the specimen and in situ margins will be evaluated.
Secondary Outcomes
No secondary outcomes reported