Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery

NCT ID: NCT01646697

Last Updated: 2017-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-07

Study Completion Date

2016-02-06

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (cytopathologic evaluation)

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.

Group Type EXPERIMENTAL

cytology specimen collection procedure

Intervention Type OTHER

Undergo cytopathologic sample collection

Interventions

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cytology specimen collection procedure

Undergo cytopathologic sample collection

Intervention Type OTHER

Other Intervention Names

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cytologic sampling

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Bloomston, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2012-00926

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-10110

Identifier Type: -

Identifier Source: org_study_id

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