Biopsy, Fine-Needle Clinical Trial
Official title:
Randomized Controlled Trial of Endoscopic Ultrasound Guided Fine Needle Aspiration of Solid Lesions With and Without a Stylet
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.
Status | Completed |
Enrollment | 137 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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Chhieng DC, Jhala D, Jhala N, Eltoum I, Chen VK, Vickers S, Heslin MJ, Wilcox CM, Eloubeidi MA. Endoscopic ultrasound-guided fine-needle aspiration biopsy: a study of 103 cases. Cancer. 2002 Aug 25;96(4):232-9. — View Citation
Eloubeidi MA, Chen VK, Eltoum IA, Jhala D, Chhieng DC, Jhala N, Vickers SM, Wilcox CM. Endoscopic ultrasound-guided fine needle aspiration biopsy of patients with suspected pancreatic cancer: diagnostic accuracy and acute and 30-day complications. Am J Gastroenterol. 2003 Dec;98(12):2663-8. — View Citation
Eloubeidi MA, Jhala D, Chhieng DC, Chen VK, Eltoum I, Vickers S, Mel Wilcox C, Jhala N. Yield of endoscopic ultrasound-guided fine-needle aspiration biopsy in patients with suspected pancreatic carcinoma. Cancer. 2003 Oct 25;99(5):285-92. — View Citation
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Nguyen YP, Maple JT, Zhang Q, Ylagan LR, Zhai J, Kohlmeier C, Jonnalagadda S, Early DS, Edmundowicz SA, Azar RR. Reliability of gross visual assessment of specimen adequacy during EUS-guided FNA of pancreatic masses. Gastrointest Endosc. 2009 Jun;69(7):1264-70. doi: 10.1016/j.gie.2008.08.030. Epub 2009 Feb 24. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare Adequacy of Diagnoses in Passes With and Without a Stylet | The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet. There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes. |
At the time of EUS-FNA procedure (Day 1) | No |
Secondary | Degree of Cellularity | Percentage of area of slide that contains cells of the representative lesion | At the time of EUS-FNA procedure (Day 1) | No |
Secondary | Degree of Cellularity | Number of cells per slide | At the time of EUS-FNA procedure (Day 1) | No |
Secondary | Adequacy of Specimen | At the time of EUS-FNA procedure (Day 1) | No | |
Secondary | Contamination | Percentage of area of slide that represents GI contamination | At the time of EUS-FNA procedure (Day 1) | No |
Secondary | Amount of Blood | At the time of EUS-FNA procedure (Day 1) | No |
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