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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Recruitment Status : Withdrawn (Funding issues)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

Tracking Information
First Submitted Date  ICMJE October 20, 2016
First Posted Date  ICMJE October 25, 2016
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE October 1, 2016
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Gastrointestinal Subepithelial Tumors
Intervention  ICMJE
  • Procedure: Device: 22G FNA needle
  • Procedure: Device: 20G FNB needle
Study Arms  ICMJE
  • Active Comparator: EUS-FNA
    Device: 22G FNA needle
    Intervention: Procedure: Device: 22G FNA needle
  • Experimental: EUS-FNB
    Device: 20G FNB needle
    Intervention: Procedure: Device: 20G FNB needle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 11, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2016)
61
Actual Study Completion Date  ICMJE December 1, 2016
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02943837
Other Study ID Numbers  ICMJE AMCSMT 001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kee Don Choi, Asan Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Asan Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Asan Medical Center
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP