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

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00716196
First received: July 15, 2008
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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
Suspected Malignant Lesions

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During EUS

Further study details as provided by Indiana University:

Study Start Date: March 2005
Study Completion Date: July 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 15, 2008
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
thin prep
EUS

ClinicalTrials.gov processed this record on November 23, 2014