22G FNA Needle vs. 22G ProCore Needle
February 9, 2018 updated by: AdventHealth
Randomized Trial Comparing the 22-gauge Aspiration and 22-gauge Biopsy Needles for EUS-guided Sampling of Solid Pancreatic Mass Lesions
The aim of this research study is to identify the best needle for performing biopsy during EUS procedures.
There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue.
It is not clear at this point which of the two needles is superior for performing biopsy.
This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this randomized trial, the 22G standard fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound.
Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
-All patients with solid pancreatic mass lesions
Exclusion Criteria:
- Coaguloapthy,
- minors,
- prgenant patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 22G ProCore biopsy needle
Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the standard FNA needle.
|
Tissue will be acquired with the 22G Procore biopsy needle and the sample will be compared to the sample obtained with the 22G standard FNA needle.
Other Names:
|
|
ACTIVE_COMPARATOR: 22G standard FNA needle
Using the 22G standard fine needle aspiration needle (FNA) for sampling pancreatic mass lesions, the tissue obtained will be compared to the 22 G ProCore needle.
|
Tissue will be acquired with the 22G standard FNA biopsy needle and the sample will be compared to the sample obtained with the 22G ProCore biopsy needle.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compare the Median Number of Passes Required to Establish a Diagnosis
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnosis Achieved With the Needle
Time Frame: 6 months
|
6 months
|
|
|
Technical Failure
Time Frame: 6 months
|
Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (ACTUAL)
September 1, 2011
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
July 12, 2011
First Submitted That Met QC Criteria
July 13, 2011
First Posted (ESTIMATE)
July 14, 2011
Study Record Updates
Last Update Posted (ACTUAL)
March 9, 2018
Last Update Submitted That Met QC Criteria
February 9, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F110506010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.