CompletedNot Applicable

The Cellularity Yield of Three Different 22-gauge FNA Needles

United States107 participantsStarted 2012-09

Plain-language 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.

Who can participate

Age range

18 Years – 88 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles

Timeframe: 2 days after the procedure

Trial details

NCT IDNCT01916421

SponsorTexas Tech University Health Sciences Center, El Paso

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

View on ClinicalTrials.gov More Pancreatic or Peripancreatic Lesions trials