EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors
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ClinicalTrials.gov Identifier: NCT02943837 |
Recruitment Status :
Withdrawn
(Funding issues)
First Posted : October 25, 2016
Last Update Posted : January 13, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Subepithelial Tumors | Procedure: Device: 22G FNA needle Procedure: Device: 20G FNB needle | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Actual Study Start Date : | October 1, 2016 |
Actual Primary Completion Date : | December 1, 2016 |
Actual Study Completion Date : | December 1, 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: EUS-FNA
Device: 22G FNA needle
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Procedure: Device: 22G FNA needle |
Experimental: EUS-FNB
Device: 20G FNB needle
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Procedure: Device: 20G FNB needle |
- Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis [ Time Frame: 12 months ]
Gold standard diagnosis is defined as;
- in operated patients; histological assessment of the surgical resection specimen
- in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of FNA and FNB samples and imaging studies)

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Ages Eligible for Study: | 19 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Esophageal, gastric, or duodenal SET over 2 cm
- Hypoechoic lesion including 4th layer on EUS
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
Responsible Party: | Kee Don Choi, Associate professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT02943837 |
Other Study ID Numbers: |
AMCSMT 001 |
First Posted: | October 25, 2016 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | January 2021 |