The Cellularity Yield of Three Different 22-gauge FNA Needles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.

NCT02246322

Pancreatic Cancer Neuroendocrine Tumors Lymphadenopathies +2 more

UNKNOWN NA

Comparison of EUS-Guided Fine Needle Aspiration Technique

NCT01923883

EUS-FNA Cytodiagnosis

UNKNOWN NA

Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition

NCT05434247

Biopsy, Needle

COMPLETED NA

A Randomized Controlled Trial Of Endoscopic Ultrasound-Guided Fine-Needle Aspiration With And Without A Stylet

NCT01213290

Mediastinal or Intra-abdominal Lymphadenopathy, Pancreatic Masses, Left Adrenal Masses, +2 more

UNKNOWN NA

Endoscopic Ultrasonography (EUS) Guided Fine Needle Aspiration Using Free Stylet 22g and 25 g Needles

NCT01543282

Solid Neoplasms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EZ Shot

Group Type ACTIVE_COMPARATOR

Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Intervention Type PROCEDURE

Expect™

Group Type ACTIVE_COMPARATOR

Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Intervention Type PROCEDURE

EchoTip® Ultra

Group Type ACTIVE_COMPARATOR

Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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