Trial Comparing 19 and 25-gauge EUS-FNA Needles

Study Overview
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Brief Summary
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This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.

Detailed Description
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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.

Official Title
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Multi-Center Randomized Trial Comparing 19 and 25-gauge Needles for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass Lesions

Conditions
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Cancer of Pancreas, Pancreatic Neoplasm

Intervention / Treatment
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* Procedure: Pancreatic Biopsy
* Procedure: Histological Samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 19G FNA needle<br>Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy. | Procedure: Pancreatic Biopsy<br>* 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.<br>Procedure: Histological Samples<br>* 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.<br>|
| Active Comparator: 25G FNA needle<br>Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy. | Procedure: Pancreatic Biopsy<br>* 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.<br>Procedure: Histological Samples<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 hours | 
| Complications | The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation. | 30 days |