NCT02943837

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

October 20, 2016

Last Update Submit

January 11, 2021

Conditions

Gastrointestinal Subepithelial Tumors

Outcome Measures

Primary Outcomes (1)

  • 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; 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)

    12 months

Study Arms (2)

EUS-FNA

ACTIVE COMPARATOR

Device: 22G FNA needle

Procedure: Device: 22G FNA needle

EUS-FNB

EXPERIMENTAL

Device: 20G FNB needle

Procedure: Device: 20G FNB needle

Interventions

Device: 22G FNA needlePROCEDURE
EUS-FNA
Device: 20G FNB needlePROCEDURE
EUS-FNB

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Esophageal, gastric, or duodenal SET over 2 cm
  • Hypoechoic lesion including 4th layer on EUS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 25, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 13, 2021

Record last verified: 2021-01