Evaluating the Number of Passes Required for Diagnostic Cell Block During EUS-FNA of Solid Pancreatic Mass Lesions

Study Overview
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Brief Summary
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This study will test the amount of tissue, called cell block, obtained from your pancreas. Patients who are asked to participate in this study have a growth (mass) in the pancreas that needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number of times the doctor biopsies the mass), at this time we do not know the ideal number of passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this study is to compare the amount of tissue obtained with 2 passes versus 4 passes.

Detailed Description
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Primary Aim: To compare the number of passes required for obtaining adequate cell block material during EUS-guided FNA of solid pancreatic mass lesions. Primary Research Hypothesis: More specimen is required to obtain definitive diagnosis on cell block. This translates to less need for repeat procedures (due to nondiagnostic index procedure due to inadequate FNA passes), prompt treatment to patients and better use of health care resources. Therefore, we will be comparing 2 versus 4 FNA passes to determine which number of FNA pases will yield an adequate diagnostic cell block. Secondary Aims: To compare the rate of complications when performing 2 versus 4 EUS-FNA passes of solid pancreatic mass lesions. Secondary Research Hypothesis: EUS-guided FNA is a safe procedure with a complication rate of < 1%. By performing more (four) NA passes one is likely to yield a better quality cell block while at the same time without compromising patient safety.

Official Title
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A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block During Endoscopic Ultrasound-Fine Needle Aspiration of Solid Pancreatic Mass Lesions

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: EUS FNA with 2 passes
* Procedure: EUS FNA with 4 passes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions 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 and databases)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 89 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: EUS FNA with 2 passes<br>biopsy with 2 passes of the needle | Procedure: EUS FNA with 2 passes<br>* biopsy with 2 passes<br>* Other names: FNA;|
| Active Comparator: EUS FNA with 4 passes<br>biopsy with 4 passes of the needle | Procedure: EUS FNA with 4 passes<br>* biopsy with 4 passes<br>* Other names: FNA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of passes | The primary endpoint of the study is to compare the number of passes required to make definitive diagnosis on cell block. This will be assessed by amount (quantity) of the sample to make the diagnosis proportionate to which group the subject was randomized to (two passes versus four passes). | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cell block, number of passes