Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs

Study Overview
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Brief Summary
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The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.

Official Title
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Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions

Conditions
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Pancreas Neoplasm, Pancreas Cancer

Intervention / Treatment
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* Device: ProControl, MediGlobe
* Device: TopGain, Medi-Globe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent. Exclusion Criteria: Patients with uncorrected coagulopathies (INR >1.5 or platelet count <50,000) or patients treated with anticoagulants that cannot be discontinued. Pregnant or lactating females. Interposed, large vessels between the transducer and the target lesion.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FNA<br> | Device: ProControl, MediGlobe<br>* standard 22G FNA needle<br>|
| Experimental: FNB<br> | Device: TopGain, Medi-Globe<br>* novel 22G crown-cut FNB needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of tissue micro-fragments | Comparison of median number of tissue micro-fragments | 1 month | 
| Diagnostic tissue area | Comparison of total diagnostic tissue area in um2 | 1 month | 
| Total tissue area | Comparison of total total tissue area in um2 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | diagnostic yield - defined by percentage of diagnostic samples in each group | 1 month | 
| Diagnostic performance | Sensitivity and specificity, where final diagnosis is either established by subsequent histopathological confirmation or other evidence (clinical, radiological) of malignant disease at a minimum of 12 months of follow-up | 12 month | 
| Adverse event rate | Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy | 1 month | 
| Mean DNA concentration |  | 6 months | 
| Suitability for molecular analyses | Percentage of samples where NGS analysis was successful | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fine needle aspiration, fine needle biopsy, solid pancreatic lesion, pancreatic neoplasm, pancreatic cancer, endoscopic ultrasound, EUS-FNA, EUS-FNB