A Multicenter randomized trial, comparing a 25G EUS Fine Needle Aspiration (FNA) device with a 20G EUS ProCore Fine Needle Biopsy (FNB) device
Completed
- Conditions
- or submucosal lesionsuspected mass lesion. lymph node1001799010027655
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
- Patients referred for EUS-guided tissue acquisition because of (I) a pancreatic mass lesion, (II) a suspicious lymph node, or (III) another submucosal or undefined mass(non-pancreatic)
- Age >=18 years
- Written informed consent
- Lesion can be visualised by EUS and is >=1 cm in size
Exclusion Criteria
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma
- Use of anticoagulants that can not be discontinued, in order to guarantee an INR below 1.5
- Purely cystic lesions
- Previous inclusion in the current study
- Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint is the diagnostic performance of the needles, measured<br /><br>against the gold standard diagnosis (based on the surgical resection specimen<br /><br>or, in non-operated patients, the outcome of the diagnostic work-up (i.e.<br /><br>tissue sampling and imaging studies), confirmed by a compatible clinical<br /><br>disease course). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include:<br /><br><br /><br>I. technical success<br /><br>II, obtained specimen specifics, such as; quality, quantity, and pathological<br /><br>classification (cytology, cell-block, or histology)<br /><br>III. procedural aspects, such as safety, the yield of a single needle pass, and<br /><br>the value of on-site pathological evaluation<br /><br>IV. the inter-observer variation among pathologists, in evaluating the<br /><br>specimens</p><br>