EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02943837

Enrollment

Registered

2016-10-25

Start date

2016-10-01

Completion date

2016-12-01

Last updated

2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Subepithelial Tumors

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.

Interventions

PROCEDUREDevice: 22G FNA needle

PROCEDUREDevice: 20G FNB needle

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026