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

Asan Medical Center

Status: Withdrawn

Conditions: Gastrointestinal Subepithelial Tumors

Treatments: Procedure: Device: 22G FNA needle; Procedure: Device: 20G FNB needle

Study type: Interventional

Funder types: Other

Identifiers

NCT02943837

AMCSMT 001

Details and patient eligibility

About

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.

Sex: All

Ages: 19 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

EUS-FNA

Active Comparator group

Description:

Device: 22G FNA needle

Treatment:

Procedure: Device: 22G FNA needle

EUS-FNB

Experimental group

Description:

Device: 20G FNB needle

Treatment:

Procedure: Device: 20G FNB needle