Clinical trial NCT01916421: The Cellularity Yield of Three Different 22-gauge FNA Needles
Official title: The Cellularity Yield of Three Different 22-gauge Endoscopic Ultrasound Fine Needle Aspiration Needles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic or Peripancreatic Lesions
Lesions in the Esophagus, Stomach, Duodenum or Rectum
Mediastinal ( Chest) Masses
Enlarged Lymph Nodes
Keywords: Pancreatic adenocarcinoma
lymphadenopathy
Endoscopic ultrasound
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles
timeFrame: 2 days after the procedure
Secondary outcomes:
measure: Compare the complication rate between the three commercially available 22 gauge EUS needles.
timeFrame: up to 1 month after the procedure
measure: Compare the number of FNA needles passes required to reach the diagnosis.
timeFrame: During the procedure ( 30 -45 minutes)
measure: Compare the technical success of the three commercially available 22 gauge EUS needles
timeFrame: During the procedure ( 30-45 minutes)
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center at El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center, El Paso
name: Mohamed O Othman, MD
role: PRINCIPAL_INVESTIGATOR
References: