Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
August 2, 2017 updated by: AdventHealth
Randomized Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
This study will test two different needles for performing a biopsy of the pancreas during endoscopic ultrasound (EUS) procedures.
Patients who are asked to participate in this study have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a diagnosis can be made.
The biopsy can be performed using either a 19 or 25-Gauge needle.
The purpose of this study is to compare which of the two needles is better for performing biopsies of the pancreas on masses that are greater than 35mm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) can be performed using the 25, 22 or 19 gauge (G) needles.
Randomized trials have shown that all three needles are safe and perform equally well.
However, in a retrospective study, the diagnostic sensitivity of EUS-FNA for pancreatic masses that measured more than 35mm was less compared to smaller size masses.
This is because larger size tumors have more necrosis and it is difficult to identify cancer cells in them to make a diagnosis.
Therefore, more biopsies must be performed in larger size tumors to establish a diagnosis.
In previous studies it has been shown that the larger 19G needles procure larger and better quality tissue.
Therefore, our hypothesis is that, when a larger 19G needle is used to FNA tumors more than 35mm, a diagnosis can be achieved with fewer passes.
Study Type
Interventional
Enrollment (Actual)
51
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
-
-
Florida
-
Orlando, Florida, United States, 32803
- Florida Hospital
-
-
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 to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions greater than 35 mm on computed tomography (CT) that require FNA.
Exclusion Criteria:
- Age < 19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
- Unable to consent
- Non-English speaking patients
- Participation in any other clinical trial (excluding registries or databases)
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 19 Gauge needle biopsy
biopsy with 19 gauge needle
|
biopsy with 19 gauge needle
Other Names:
|
|
Active Comparator: 25 gauge needle biopsy
biopsy with 25 gauge needle
|
biopsy with 25 gauge needle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of passes
Time Frame: Up to 12 months
|
The use of a 19G FNA needle reduces the number of passes required to establish a diagnosis in pancreatic tumors that are greater than 35mm in size.
This translates to less sedation, faster patient recovery, better safety and time efficiency.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Complication
Time Frame: Up to 12 months
|
To compare the rate of complications associated with the 19G and 25G needles when sampling pancreatic tumors greater than 35mm in size. Also, the rate of needle dysfunction will be compared. Needle dysfunction is defined as, the need to use more than one needle per pancreatic tumor in an individual patient. |
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
February 26, 2013
First Submitted That Met QC Criteria
March 19, 2013
First Posted (Estimate)
March 21, 2013
Study Record Updates
Last Update Posted (Actual)
August 3, 2017
Last Update Submitted That Met QC Criteria
August 2, 2017
Last Verified
August 1, 2017
More Information
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.