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

Sponsor
Indiana University (Other)
Overall Status
Completed
CT.gov ID
NCT00716196
Collaborator
(none)
1
Location
40
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Mar 1, 2005
    Actual Primary Completion Date :
    Apr 1, 2007
    Actual Study Completion Date :
    Jul 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Clarian/Indiana University Hospital Indianapolis Indiana United States 46202

      Sponsors and Collaborators

      • Indiana University

      Investigators

      • Principal Investigator: Julia K LeBlanc, MD, MPH, Indiana University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00716196
      Other Study ID Numbers:
      • 0502-23
      First Posted:
      Jul 16, 2008
      Last Update Posted:
      Sep 12, 2012
      Last Verified:
      Sep 1, 2012
      Keywords provided by , ,
      thin prep
      EUS

      Study Results

      No Results Posted as of Sep 12, 2012