Pancreas Cancer, Pancreas Neoplasm
Conditions
Keywords
fine needle aspiration, fine needle biopsy, solid pancreatic lesion, pancreatic neoplasm, pancreatic cancer, endoscopic ultrasound, EUS-FNA, EUS-FNB
Brief summary
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.
Interventions
DEVICEProControl, MediGlobe
standard 22G FNA needle
DEVICETopGain, Medi-Globe
novel 22G crown-cut FNB needle
Sponsors
Gastro Unit, Endoscopy Section, Hvidovre Hospital, Denmark
Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania
Endoscopy Unit, Odense Hospital, Denmark
Peter Vilmann MD, DSc, HC, FASGE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of tissue micro-fragments | 1 month | Comparison of median number of tissue micro-fragments |
| Diagnostic tissue area | 1 month | Comparison of total diagnostic tissue area in um2 |
| Total tissue area | 1 month | Comparison of total total tissue area in um2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 1 month | Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy |
| Suitability for molecular analyses | 6 months | Percentage of samples where NGS analysis was successful |
| Mean DNA concentration | 6 months | — |
| Diagnostic yield | 1 month | diagnostic yield - defined by percentage of diagnostic samples in each group |
| Diagnostic performance | 12 month | 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 |
Countries
Denmark
Contacts
Primary ContactBojan Kovacevic
Outcome results
None listed