N/A
N=137
EUS-guided Fine Needle Aspiration (FNA) With and Without the Use of a Stylet
Biopsy, Fine-Needle · Biopsy, Fine-Needle/Methods · Endosonography
Bottom Line
View on ClinicalTrials.gov: NCT01316614 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Compare Adequacy of Diagnoses in Passes With and Without a Stylet — 80; 68; 21; 18 passes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FNA with and without a stylet (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Adequacy of Diagnoses in Passes With and Without a Stylet |
80; 68; 21; 18; 23; 15 | — |
| SECONDARY Degree of Cellularity |
127; 120; 70; 82; 78; 73 | — |
| SECONDARY Degree of Cellularity |
127; 120; 70; 82; 78; 73 | — |
| SECONDARY Adequacy of Specimen |
87; 78; 188; 197 | — |
| SECONDARY Contamination |
212; 220; 52; 47; 7; 5 | — |
| SECONDARY Amount of Blood |
126; 120; 82; 86; 67; 69 | — |
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.
Eligibility Criteria
Inclusion Criteria
- patients referred to the Washington University Interventional Endoscopy Division for EUS-guided FNA of a solid lesion (e.g. pancreatic mass, gastric wall mass, or lymphadenopathy)
Exclusion Criteria
- Patients <18 years of age
- patients who cannot provide independent informed consent (i.e. patients with dementia or with a health care proxy)
- pregnant women (as determined by pregnancy test given as part of standard of care)
- prisoners
Data sourced from ClinicalTrials.gov (NCT01316614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.