Multi-Center Randomized Trial Comparing 19 and 25-gauge Needles for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AdventHealth
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Median Number of Passes to Establish Diagnosis
Study Overview
Brief Summary
This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1) Patients with solid pancreatic mass lesions.
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
Arms & Interventions
19G FNA needle
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
Intervention: Pancreatic Biopsy (Procedure)
19G FNA needle
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
Intervention: Histological Samples (Procedure)
25G FNA needle
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.
Intervention: Pancreatic Biopsy (Procedure)
25G FNA needle
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.
Intervention: Histological Samples (Procedure)
Outcomes
Primary Outcomes
Median Number of Passes to Establish Diagnosis
Time Frame: 5 months
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.
Secondary Outcomes
- Complications(30 days)
- Procurement of Histological Samples(30 days)
- Needle Dysfunction(2 hours)