Trial Comparing 19 and 25-gauge EUS-FNA Needles

Not Applicable

Completed

• Conditions: Cancer of Pancreas; Pancreatic Neoplasm
• Interventions: Procedure: Pancreatic Biopsy; Procedure: Histological Samples

• Registration Number: NCT01677312
• Lead Sponsor: AdventHealth

Brief Summary

This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.

Detailed Description

The study compares the median number of passes to establish a definitive diagnosis using the 19G or 25G needles. Also, the ability of both needles to procure a histological core tissue is assessed.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-09-03
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2015-03-31
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-03
• Last Update Submitted: 2020-03-03
• Results First Posted: 2020-03-17
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
19G FNA needle	Histological Samples	Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
25G FNA needle	Histological Samples	Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.
19G FNA needle	Pancreatic Biopsy	Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
25G FNA needle	Pancreatic Biopsy	Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.

Primary Outcome Measures

Name	Time	Method
Median Number of Passes to Establish Diagnosis	5 months	To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.

Secondary Outcome Measures

Name	Time	Method
Complications	30 days	The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.
Procurement of Histological Samples	30 days	The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.
Needle Dysfunction	2 hours	The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.

Trial Locations

Locations (2)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States