NCT01677312

Trial Comparing 19 and 25-gauge EUS-FNA Needles

Multi-Center Randomized Trial Comparing 19 and 25-gauge Needles for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of Pancreas
• Pancreatic Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Pancreatic Biopsy	A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
PROCEDURE	Histological Samples	The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-09-03
• Last updated: 2020-03-17
• Results posted: 2020-03-17

Locations

2 sites across 1 country: United States