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

NCT ID: NCT02943837

Last Updated: 2021-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2016-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Subepithelial Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EUS-FNA

Device: 22G FNA needle

Group Type ACTIVE_COMPARATOR

Device: 22G FNA needle

Intervention Type PROCEDURE

EUS-FNB

Device: 20G FNB needle

Group Type EXPERIMENTAL

Device: 20G FNB needle

Intervention Type PROCEDURE

Interventions

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Device: 22G FNA needle

Intervention Type PROCEDURE

Device: 20G FNB needle

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kee Don Choi

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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AMCSMT 001

Identifier Type: -

Identifier Source: org_study_id

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