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Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection


N/A
18 Years
80 Years
Open (Enrolling)
Both
Pancreatic Cancer, Adenocarcinoma

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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 CenterColumbus, Ohio  43210