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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01646697
First Posted: July 20, 2012
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
  Purpose
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

Condition Intervention
Pancreatic Cancer Adenocarcinoma Other: cytology specimen collection procedure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Enrollment: 90
Actual Study Start Date: November 7, 2011
Study Completion Date: February 6, 2016
Primary Completion Date: February 6, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: cytology specimen collection procedure
Undergo cytopathologic sample collection
Other Name: cytologic sampling

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646697


Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Mark Bloomston, MD Ohio State University
  More Information

Additional Information:
Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01646697     History of Changes
Other Study ID Numbers: OSU-10110
NCI-2012-00926 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: July 18, 2012
First Posted: July 20, 2012
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Ohio State University Comprehensive Cancer Center:
pancreatic cancer
adenocarcinoma
pancreatic resection

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases