Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures

NCT ID: NCT02366858

Last Updated: 2017-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-06-30

Brief Summary

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The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the need to use the 19 gauge needle for core tissue procurement.

Detailed Description

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Inclusion Criteria

1. Age under 19 years
2. Pregnant women will be excluded. This will be confirmed by self-report

Exclusion Criteria

1. Age under 19 years
2. Pregnant women will be excluded. This will be confirmed by self-report

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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19 gauge

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle.

Group Type ACTIVE_COMPARATOR

19 gauge

Intervention Type PROCEDURE

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle

22 gauge

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle.

Group Type ACTIVE_COMPARATOR

19 gauge

Intervention Type PROCEDURE

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle

22 gauge

Intervention Type PROCEDURE

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle

Interventions

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19 gauge

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle

Intervention Type PROCEDURE

22 gauge

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients who are referred to Florida Hospital Center for Interventional Endoscopy for a EUS FNA for core biopsy (19 gauge needle biopsy) who have needle dysfunction (This occurs in about 10% of patients)

Exclusion Criteria

* Age under 19 years
* Pregnant women will be excluded. This will be confirmed by self-report
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyam Varadarajulu, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

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Florida Hospital

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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510467

Identifier Type: -

Identifier Source: org_study_id

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