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

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ClinicalTrials.gov Identifier: NCT00716196
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : September 12, 2012
Sponsor:
Information provided by:
Indiana University

Brief Summary:
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.

Condition or disease
Suspected Malignant Lesions

Detailed Description:
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

Study Type : Observational
Time Perspective: Prospective
Official Title: A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During EUS
Study Start Date : March 2005
Primary Completion Date : April 2007
Study Completion Date : July 2008




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample from patients presenting at the GI endoscopy unit for an EUS.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716196


Locations
United States, Indiana
Clarian/Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Julia K LeBlanc, MD, MPH Indiana University

Responsible Party: Dr. Julia LeBlanc, MD, MPH, Indiana University, Department of Medicine
ClinicalTrials.gov Identifier: NCT00716196     History of Changes
Other Study ID Numbers: 0502-23
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012

Keywords provided by Indiana University:
thin prep
EUS