This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.
The study compares the median number of passes to establish a definitive diagnosis using the 19G or 25G needles. Also, the ability of both needles to procure a histological core tissue is assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
72
A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Florida Hospital
Orlando, Florida, United States
Median Number of Passes to Establish Diagnosis
To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.
Time frame: 5 months
Procurement of Histological Samples
The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.
Time frame: 30 days
Needle Dysfunction
The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.
Time frame: 2 hours
Complications
The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.
Time frame: 30 days
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