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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
68
standard 22G FNA needle
novel 22G crown-cut FNB needle
Gastro Unit, Division of Endoscopy
Herlev, Danmark, Denmark
RECRUITINGAmount of tissue micro-fragments
Comparison of median number of tissue micro-fragments
Time frame: 1 month
Diagnostic tissue area
Comparison of total diagnostic tissue area in um2
Time frame: 1 month
Total tissue area
Comparison of total total tissue area in um2
Time frame: 1 month
Diagnostic yield
diagnostic yield - defined by percentage of diagnostic samples in each group
Time frame: 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
Time frame: 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
Time frame: 1 month
Mean DNA concentration
Time frame: 6 months
Suitability for molecular analyses
Percentage of samples where NGS analysis was successful
Time frame: 6 months
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