Trial record 13 of 1646 for:    Open Studies | "Lymphatic Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Texas Tech University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01916421
First received: June 23, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Pancreatic or Peripancreatic Lesions
Lesions in the Esophagus, Stomach, Duodenum or Rectum
Mediastinal ( Chest) Masses
Enlarged Lymph Nodes
Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • 1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles [ Time Frame: 2 days after the procedure ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Compare the complication rate between the three commercially available 22 gauge EUS needles. [ Time Frame: up to 1 month after the procedure ] [ Designated as safety issue: Yes ]
    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.

  • Compare the number of FNA needles passes required to reach the diagnosis. [ Time Frame: During the procedure ( 30 -45 minutes) ] [ Designated as safety issue: No ]
    The number of passes required to reach the diagnosis

  • Compare the technical success of the three commercially available 22 gauge EUS needles [ Time Frame: During the procedure ( 30-45 minutes) ] [ Designated as safety issue: No ]
    The ability of the needle to perform the intended purpose of the procedure ( reach the lesion and obtain sufficient tissues)


Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EZ Shot 2 (Olympus America Inc., Center Valley, PA, USA) 22 g Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
Active Comparator: Expect™ (Boston Scientific Natick, MA, USA) 22 gauge needle Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
Active Comparator: EchoTip® Ultra (Cook Endoscopy, Winston-Salem, NC, USA) 22 g Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

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

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916421

Locations
United States, Texas
Texas Tech University Health Sciences Center at El Paso Recruiting
El Paso, Texas, United States, 79905
Contact: Mohamed O Othman, MD    914-545-6618      
Principal Investigator: Mohamed O Othman, MD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01916421     History of Changes
Other Study ID Numbers: E12097
Study First Received: June 23, 2013
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Pancreatic adenocarcinoma
lymphadenopathy
Endoscopic ultrasound

Additional relevant MeSH terms:
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014