Prospective Evaluation of Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy (EUS-FNAB) in the Absence of Rapid Onsite Evaluation
NCT ID: NCT02079285
Last Updated: 2016-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2014-04-30
2015-09-30
Brief Summary
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\<Methods\> All EUS-FNAB procedures will be performed by an experienced endosonographer and the adequacy of specimens obtained during EUS-FNAB will be also assessed by a same endosonographer. A specimen will be considered adequate if there is an adequate number of representative cells from the lesion. Samples considered to be adequate will be then interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive change, or negative for malignancy. Performance characteristics of EUS-FNAB including sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up of more than 6 months with repeat imagings.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EUS-FNA
Any patients who will undergo EUS-FNA for pancreas lesion during the study period
EUS-FNA
Interventions
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EUS-FNA
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
85 Years
ALL
No
Sponsors
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Kangbuk Samsung Hospital
OTHER
Responsible Party
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Hong Joo Kim
MD
Locations
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Sungkyunkwan University Kangbuk Samsung Hospital
Seoul, , South Korea
Sungkyunkwan University Kangbuk Samsung Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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FNASROSE
Identifier Type: -
Identifier Source: org_study_id
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