The Cellularity Yield of Three Different 22-gauge FNA Needles

Not Applicable

Completed

• Conditions: Pancreatic or Peripancreatic Lesions; Lesions in the Esophagus, Stomach, Duodenum or Rectum; Mediastinal ( Chest) Masses; Enlarged Lymph Nodes
• Interventions: Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

• Registration Number: NCT01916421
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Brief 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-06-23
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-05
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

1. Adult patients (18-88) who are undergoing EUS FNA of pancreatic or peripancreatic lesions
2. Adult patients (18-88) who are undergoing EUS FNA of submucosal masses in the esophagus, stomach, duodenum or rectum
3. Adult patients (18-88) who are undergoing EUS FNA of mediastinal masses.
4. Adult patients (18-88) who are undergoing EUS FNA of enlarged lymph nodes

Exclusion Criteria

1. Patients younger than 18 yrs old or older than 88 yrs.
2. Pregnant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EchoTip® Ultra	Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)	-
EZ Shot	Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)	-
Expect™	Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)	-

Primary Outcome Measures

Name	Time	Method
1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles	2 days after the procedure	Cellularity score will be assessed by the cytopathologist using the scoring system from 0 to 10 score. This scoring system evaluate the amount of blood, malignant cells and contaminant cells. The system is a modified form Mair et al study. " Mair S, Dunbar F, Becker PJ, Du Plessis W. Fine needle cytology--is aspiration suction necessary? A study of 100 masses in various sites. Acta cytologica 1989;33:809-13."

Secondary Outcome Measures

Name	Time	Method
Compare the number of FNA needles passes required to reach the diagnosis.	During the procedure ( 30 -45 minutes)	The number of passes required to reach the diagnosis
Compare the complication rate between the three commercially available 22 gauge EUS needles.	up to 1 month after the procedure	The patient will be contacted after the procedure by one week to review any procedure complications. The patient's medical records may be reviewed for up to 6 months after the procedure to review the surgical resection results or the long-term follow-up results. If the patient receives his further care in another hospital, the patient will be contacted by phone for follow-up for a maximum period of 6 months.
Compare the technical success of the three commercially available 22 gauge EUS needles	During the procedure ( 30-45 minutes)	The ability of the needle to perform the intended purpose of the procedure ( reach the lesion and obtain sufficient tissues)

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center at El Paso; 🇺🇸 El Paso, Texas, United States