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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02366858
• Other study ID #: 510467
• Status: Withdrawn
• Phase: N/A
• First received: January 15, 2014
• Last updated: February 13, 2017
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• 19 gauge
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

Locations

Country	Name	City	State
United States	Florida Hospital	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	22 gauge needle	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.	72 hours