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Completed

NCT Number: NCT01916421

The Cellularity Yield of Three Different 22-gauge FNA 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.

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Key information

Conditions

Pancreatic or Peripancreatic Lesions Enlarged Lymph Nodes Hemic and Lymphatic Diseases Lesions in the Esophagus, Stomach, Duodenum or Rectum Lymphadenopathy Lymphatic Diseases Mediastinal ( Chest) Masses

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Health Sciences Center at El Paso

El Paso, Texas, 79905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Procedure

Primary outcomes

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

    Time frame: 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 outcomes

  1. Compare the complication rate between the three commercially available 22 gauge EUS needles.

    Time frame: 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.

  2. Compare the number of FNA needles passes required to reach the diagnosis.

    Time frame: During the procedure ( 30 -45 minutes)

    The number of passes required to reach the diagnosis

  3. Compare the technical success of the three commercially available 22 gauge EUS needles

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2013
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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