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The Cellularity Yield of Three Different 22-gauge FNA Needles

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

About this trial

This is an interventional diagnostic trial for Pancreatic or Peripancreatic Lesions focused on measuring Pancreatic adenocarcinoma, lymphadenopathy, Endoscopic ultrasound

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Texas Tech University Health Sciences Center at El Paso

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

EZ Shot

Expect™

EchoTip® Ultra

Arm Description

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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

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.

The number of passes required to reach the diagnosis

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

The ability of the needle to perform the intended purpose of the procedure ( reach the lesion and obtain sufficient tissues)

Full Information

NCT ID

NCT01916421

First Posted

June 23, 2013

Last Updated

May 15, 2017

Sponsor

Texas Tech University Health Sciences Center, El Paso

1. Study Identification

Unique Protocol Identification Number

NCT01916421

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas Tech University Health Sciences Center, El Paso

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Pancreatic adenocarcinoma, lymphadenopathy, Endoscopic ultrasound

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EZ Shot

Arm Type

Active Comparator

Arm Title

Expect™

Arm Type

Active Comparator

Arm Title

EchoTip® Ultra

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 days after the procedure

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

up to 1 month after the procedure

Title

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

Description

The number of passes required to reach the diagnosis

Time Frame

During the procedure ( 30 -45 minutes)

Title

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

Description

The ability of the needle to perform the intended purpose of the procedure ( reach the lesion and obtain sufficient tissues)

Time Frame

During the procedure ( 30-45 minutes)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed O Othman, MD

Organizational Affiliation

Texas Tech University Health Sciences Center, El Paso

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Tech University Health Sciences Center at El Paso

City

El Paso

State/Province

Texas

ZIP/Postal Code

79905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Cellularity Yield of Three Different 22-gauge FNA Needles

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