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

Asan Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Gastrointestinal Subepithelial Tumors

Interventions

Device: 22G FNA needlePROCEDURE

Device: 20G FNB needlePROCEDURE

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis

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)

Time frame: 12 months

Data from ClinicalTrials.gov

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