Clinical trial · Interventional
EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors
NCT02943837CI-TRIAL-00049403withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Subepithelial Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Device: 20G FNB needle | Procedure | — | UNRESOLVED |
| Device: 22G FNA needle | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EUS-FNA
- description
- Device: 22G FNA needle
- interventionNames
- Procedure: Device: 22G FNA needle
- type
- EXPERIMENTAL
- label
- EUS-FNB
- description
- Device: 20G FNB needle
- interventionNames
- Procedure: Device: 20G FNB needle
Primary outcomes (1)
- measure
- Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.