A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During Endoscopic Ultrasound (EUS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-07-31

Brief Summary

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Objective: The purpose of this study was to compare the performance of the monolayer preparation (Cyto Lyt or Thin prep) to the routine use of Papanicolau methods on the analysis of specimens obtained using EUS-FNA.

Detailed Description

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Introduction: The presence of a pathologist during an endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is often a luxury. In addition, preparation of multiple slides for a fine needle aspiration can be time-consuming for the gastroenterologist who waits for verbal feedback on the adequacy of the specimen. Often, a timely diagnosis is needed to direct patient management. Currently, there is no established standard of care for EUS-FNA preparation. A liquid based cytologic fixative preparation (Thin-prep or CytoLyt), is a well-established process used by pathologists for evaluating cervical smears. It has not yet been adopted or accepted for EUS-FNA. This method combines multiple aspirates on a single slide, thereby decreasing the number of slides that need to be processed and interpreted by the pathologist

Conditions

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Suspected Malignant Lesions

Keywords

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thin prep EUS

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subjects with known or suspected malignancy (solid mass or lymph node) that are undergoing EUS will be eligible to participate in this study.
* Target lesions such as ascites and cystic lesions will not be considered for this study. However, if a patient has an abnormal solid lesion and abnormal lymph node in addition to the ascites or cystic lesion, they may still be considered for the study. That is, the solid lesions and abnormal lymph nodes are appropriate target lesions for this study.
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
* Subject must provide signed written informed consent.

Exclusion Criteria

* Subjects that have had a previous EUS-FNA are eligible for this study
* Target lesions such as ascites and cystic lesions will not be considered for this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Indiana University, Department of Medicine

Principal Investigators

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Julia K LeBlanc, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Clarian/Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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0502-23

Identifier Type: -

Identifier Source: org_study_id