NCT01916421

The Cellularity Yield of Three Different 22-gauge FNA Needles

The Cellularity Yield of Three Different 22-gauge Endoscopic Ultrasound Fine Needle Aspiration Needles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Texas Tech University Health Sciences Center, El Paso · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

Summary

Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a flexible tube with a camera and small ultrasound machine at its end )requires the use of a needle for taking the sample from the lesion or what we call "Fine needle aspiration (FNA)". Currently, FNA is done by three commercially available needles. These needles are used routinely in our institution for FNA. The data regarding the safety and the successfulness of any of these needles are lacking. We sought to compare all three commercially available needles in a prospective manner.

Detailed description

The following are being done only for research purposes; prior to performing the FNA, The patient will be randomized to one of the three commercially available FNA needles. At this time, all needles are considered equivalent and there is no medical necessity to pick one over another. The sample obtained by the needle will be assigned a quality score based on certain parameters of the sample such as the abundance of diagnostic cells and the presence of blood. We are going to collect certain information about your procedure such as the complications of the procedure, number of needle passes and final diagnosis.

Conditions

• Pancreatic or Peripancreatic Lesions
• Lesions in the Esophagus, Stomach, Duodenum or Rectum
• Mediastinal ( Chest) Masses
• Enlarged Lymph Nodes

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-08-05
• Last updated: 2017-05-17

Locations

1 site across 1 country: United States