Back to results22G FNA Needle vs. 22G ProCore Needle
Primary Purpose
Pancreatic Neoplasm
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
22G ProCore biopsy needle
22G standard FNA needle
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Neoplasm focused on measuring passes required to establish diagnosis
Eligibility Criteria
Inclusion Criteria:
-All patients with solid pancreatic mass lesions
Exclusion Criteria:
- Coaguloapthy,
- minors,
- prgenant patients
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
22G ProCore biopsy needle
22G standard FNA needle
Arm Description
Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the 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.
Outcomes
Primary Outcome Measures
Compare the Median Number of Passes Required to Establish a Diagnosis
Secondary Outcome Measures
Diagnosis Achieved With the Needle
Technical Failure
Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01394159
Brief Title
22G FNA Needle vs. 22G ProCore Needle
Official Title
Randomized Trial Comparing the 22-gauge Aspiration and 22-gauge Biopsy Needles for EUS-guided Sampling of Solid Pancreatic Mass Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm
Keywords
passes required to establish diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
22G ProCore biopsy needle
Arm Type
Active Comparator
Arm Description
Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the standard FNA needle.
Arm Title
22G standard FNA needle
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
22G ProCore biopsy needle
Other Intervention Name(s)
Biopsy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
22G standard FNA needle
Other Intervention Name(s)
biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare the Median Number of Passes Required to Establish a Diagnosis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Diagnosis Achieved With the Needle
Time Frame
6 months
Title
Technical Failure
Description
Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-All patients with solid pancreatic mass lesions
Exclusion Criteria:
Coaguloapthy,
minors,
prgenant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyam Varadarajulu, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22658389
Citation
Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.
Results Reference
derived
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22G FNA Needle vs. 22G ProCore Needle
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