NCT01916421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

June 23, 2013

Last Update Submit

May 15, 2017

Conditions

Pancreatic or Peripancreatic LesionsLesions in the Esophagus, Stomach, Duodenum or RectumMediastinal ( Chest) MassesEnlarged Lymph Nodes

Keywords

Pancreatic adenocarcinomalymphadenopathyEndoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

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

    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."

    2 days after the procedure

Secondary Outcomes (3)

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

    up to 1 month after the procedure

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

    During the procedure ( 30 -45 minutes)

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

    During the procedure ( 30-45 minutes)

Study Arms (3)

EZ Shot

ACTIVE COMPARATOR
Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Expect™

ACTIVE COMPARATOR
Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

EchoTip® Ultra

ACTIVE COMPARATOR
Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Interventions

Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)PROCEDURE
EZ ShotEchoTip® UltraExpect™

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center at El Paso

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Lymphadenopathy

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic ImagingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Mohamed O Othman, MD

    Texas Tech University Health Sciences Center, El Paso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 23, 2013

First Posted

August 5, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 17, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)