The Cellularity Yield of Three Different 22-gauge FNA Needles

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center at El Paso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EZ Shot	Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
Active Comparator: Expect™	Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
Active Comparator: EchoTip® Ultra	Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles	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."	2 days after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the complication rate between the three commercially available 22 gauge EUS needles.	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.	up to 1 month after the procedure
Compare the number of FNA needles passes required to reach the diagnosis.	The number of passes required to reach the diagnosis	During the procedure ( 30 -45 minutes)
Compare the technical success of the three commercially available 22 gauge EUS needles	The ability of the needle to perform the intended purpose of the procedure ( reach the lesion and obtain sufficient tissues)	During the procedure ( 30-45 minutes)

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Investigators: Principal Investigator: Mohamed O Othman, MD, Texas Tech University Health Sciences Center, El Paso

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 23, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pancreatic adenocarcinoma; Endoscopic ultrasound; lymphadenopathy
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: E12097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO