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

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

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Key information

Conditions

Pancreatic Cancer Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Undergo cytopathologic sample collection

Other names: cytologic sampling

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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Jul 20, 2012
Registry last updated: Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed