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

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ClinicalTrials.gov Identifier: NCT02943837
Recruitment Status : Withdrawn (Funding issues)
First Posted : October 25, 2016
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Kee Don Choi, Asan Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Subepithelial Tumors Procedure: Device: 22G FNA needle Procedure: Device: 20G FNB needle Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: EUS-FNA
Device: 22G FNA needle
 Procedure: Device: 22G FNA needle
Experimental: EUS-FNB
Device: 20G FNB needle
 Procedure: Device: 20G FNB needle


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis [ Time Frame: 12 months ]

    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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Kee Don Choi, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02943837    
Other Study ID Numbers: AMCSMT 001
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021