Forward viewing US endoscope versus standard oblique viewing US endoscope in the performance of EUS-guided fine needle aspiration of solid lesions of the gastrointestinal tract and of adjacent organs: A prospective randomized controlled study
Phase 4
Completed
- Conditions
- mass lesionssolid lesions10027655
- Registration Number
- NL-OMON37177
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Presence of a solid lesion in the GI tract or in one of the adjacent organs identified at abdominal US, CT, MRI/MRCP that needs to be samples with endoscopic ultrasonographic fine needle aspiration (EUS-FNA).
Exclusion Criteria
Patients with active coagulopathy that cannot be corrected after administration of plasma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Successful lesion identification<br /><br>* Technically successful EUS-FNA by EUS image confirming the needle into the<br /><br>lesion<br /><br>* Diagnostically successful EUS-FNA by obtainment of adequate material for<br /><br>analysis</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Comparison of the performance (sensitivity, specificity, and diagnostic<br /><br>accuracy) of the two different EUS scopes for EUS-FNA<br /><br>* Ease of procedure<br /><br>* Procedure related complications</p><br>