NCT01646697

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2016

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

4.3 years

First QC Date

July 18, 2012

Last Update Submit

June 8, 2017

Conditions

Pancreatic CancerAdenocarcinoma

Keywords

pancreatic canceradenocarcinomapancreatic resection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Diagnostic (cytopathologic evaluation)

EXPERIMENTAL

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

Interventions

cytology specimen collection procedureOTHER

Undergo cytopathologic sample collection

Also known as: cytologic sampling
Diagnostic (cytopathologic evaluation)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing pancreatic resection for a presumed, although not necessarily biopsy-proven pancreatic malignancy,
  • ages 18 years to 80 years old

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Mark Bloomston, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 20, 2012

Study Start

November 7, 2011

Primary Completion

February 6, 2016

Study Completion

February 6, 2016

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

US(1)