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

Not Applicable

Withdrawn

• Conditions: Pancreatic Cancer
• Interventions: Procedure: 19 gauge; Procedure: 22 gauge

• Registration Number: NCT02366858
• Lead Sponsor: AdventHealth

Brief Summary

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

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-19
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
22 gauge	19 gauge	Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle.
19 gauge	19 gauge	Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle.
22 gauge	22 gauge	Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle.

Primary Outcome Measures

Name	Time	Method
22 gauge needle	72 hours	Compare the quality of core tissue specimens obtained between a 19G and 22G needle by evaluating the ability to perform molecular marker studies or immunohistochemistry studies between samples obtained.

Trial Locations

Locations (1)

Florida Hospital; 🇺🇸 Orlando, Florida, United States