CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 137 enrolled
Drug / intervention
FNA with and without a styletdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01316614
NCT01316614N/ACompleted
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Randomized Controlled Trial of Endoscopic Ultrasound Guided Fine Needle Aspiration of Solid Lesions With and Without a Stylet

Washington University School of Medicine·interventional·Posted Mar 16, 2011·Updated Dec 3, 2014

In Brief

A clinical study evaluating FNA with and without a stylet for Biopsy, Fine-Needle and 2 related conditions. Completed, enrolled 137 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiopsy, Fine-Needle, Biopsy, Fine-Needle/Methods, Endosonography
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2011
Enrollment StartJul 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.3 years ago

Interventions

FNA with and without a styletdevice

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.