Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection
18 Years
80 Years
Both
Pancreatic Cancer, Adenocarcinoma
Trial Information
Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Outcome Measure:
Local recurrence at the site of resection
Outcome Description:
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.
Outcome Time Frame:
up to 2 years
Safety Issue:
No
Principal Investigator
Mark Bloomston
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University
Authority:
United States: Institutional Review Board
Study ID:
OSU-10110
NCT ID:
NCT01646697
Start Date:
November 2011
Completion Date:
Related Keywords:
- Pancreatic Cancer
- Adenocarcinoma
- pancreatic cancer
- adenocarcinoma
- pancreatic resection
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Ohio State University Medical Center | Columbus, Ohio 43210 |
