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

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Adenocarcinoma
• Interventions: Other: cytology specimen collection procedure

• Registration Number: NCT01646697
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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

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.

Study Timeline

• Study Start: 2011-11-07
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-20
• Primary Completion: 2016-02-06
• Study Completion: 2016-02-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (cytopathologic evaluation)	cytology specimen collection procedure	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.

Primary Outcome Measures

Name	Time	Method
Local recurrence at the site of resection	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.

Trial Locations

Locations (1)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States