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EUS-guided Fine Needle Aspiration (FNA) With and Without the Use of a Stylet

NCT01316614 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2014-12-03

Study results available
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Summary

The purpose of this study is to determine that there is no difference in final diagnosis of FNA specimens without a stylet, compared to using a stylet, when examined by a skilled cytopathologist.

Conditions

  • Biopsy, Fine-Needle
  • Biopsy, Fine-Needle/Methods
  • Endosonography

Interventions

DEVICE

FNA with and without a stylet

If the patient agrees to enrollment in the study, the initial stage of the EUS exam will be performed in the usual manner. If a solid lesion that requires FNA is identified, an envelope will be opened which contains a computer generated randomization sequence for all passes. These sequences will be generated by a web-based program at http://www.randomizer.org/form.htm. Passes will be made based on the randomization, either with or without a stylet. Six passes (three with a stylet and three without a stylet) will be performed on solid lesions and four passes (two with and two without a stylet) will be performed on lymph nodes. Additional passes will be made at the discretion of the endosonographer as clinically indicated but will not be included in the data.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Daniel K Mullady, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01316614 on ClinicalTrials.gov