The Cellularity Yield of Three Different 22-gauge FNA Needles

Texas Tech University Health Sciences Center, El Paso

Status: Completed

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

Treatments: Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01916421

E12097

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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107 participants in 3 patient groups

EZ Shot

Active Comparator group

Treatment:

Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Expect™

Active Comparator group

Treatment:

Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

EchoTip® Ultra

Active Comparator group

Treatment:

Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)