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

Gastrointestinal Subepithelial Tumors Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02943837
• Other study ID #: AMCSMT 001
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: January 2021
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Subepithelial Tumors

Intervention

Procedure:
• Device: 22G FNA needle

• Device: 20G FNB needle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; in operated patients; histological assessment of the surgical resection specimen; in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of FNA and FNB samples and imaging studies)	12 months