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

Pancreatic Cancer Clinical Trial

Official title:

Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646697
• Other study ID #: OSU-10110
• Secondary ID: NCI-2012-00926
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: June 8, 2017
• Start date: November 7, 2011
• Est. completion date: February 6, 2016

Study information

• Verified date: June 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 6, 2016
• Est. primary completion date: February 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• cytology specimen collection procedure
Undergo cytopathologic sample collection

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence at the site of resection	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.	up to 2 years

External Links

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