EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors
Not Applicable
Withdrawn
- Conditions
- Gastrointestinal Subepithelial Tumors
- Registration Number
- NCT02943837
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently considered the standard method for sampling SET, its diagnostic yield is generally suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate histology obtained.
Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Esophageal, gastric, or duodenal SET over 2 cm
- Hypoechoic lesion including 4th layer on EUS
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Exclusion Criteria
- SET with characteristic findings such as lipoma, vessels, or ectopic pancreas
- bleeding or rupture of SET
- platelet count <50,000 or prothrombin time INR > 1.3
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis 12 months Gold standard diagnosis is defined as;
1. in operated patients; histological assessment of the surgical resection specimen
2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of FNA and FNB samples and imaging studies)
- Secondary Outcome Measures
Name Time Method