Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02943837
  4. Details
NCT02943837 Clinical Trial

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Clinical Trial Details — Status: Withdrawn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
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design

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
See also
  Status Clinical Trial Phase
Suspended NCT04316000 - Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)
Terminated NCT03247231 - Banding Without Resection in Small Subepithelial Tumours
Completed NCT02666976 - The Prospective Study on the Effect of Ilaprazole in Non-erosive Reflux Disease Patients; Focused on Histologic Findings and Inflammatory Biomarker Phase 4
Recruiting NCT04695262 - EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors