Status:
COMPLETED
A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During Endoscopic Ultrasound (EUS)
Lead Sponsor:
Indiana University
Conditions:
Suspected Malignant Lesions
Eligibility:
All Genders
18+ years
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...
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 asp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
End Date :
July 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00716196
Start Date
March 1 2005
End Date
July 1 2008
Last Update
September 12 2012
Active Locations (1)
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1
Clarian/Indiana University Hospital
Indianapolis, Indiana, United States, 46202