Rapid on-site evaluation vs. randomly collected samples from mediastinal andabdominal lymph nodes obtained by endoscopic ultrasound-guided fine-needle-aspiratio
Recruiting
- Conditions
- lymphadenopathy
- Registration Number
- NL-OMON23056
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 234
Inclusion Criteria
≥18 years old
-EUS with FNA of a lymph node in either the mediastinum or abdomen
Exclusion Criteria
-Patients with a poor mental condition or mental retardation, unable to understand the nature and consequences of the study
-Coagulopathy (INR>1.5, platelets<50.000/mm3) which has not been corrected prior to the procedure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the percentage of cases in which the local cytopathologist correctly diagnosed the lymph node, based on the EUS-FNA samples of the lymph node
- Secondary Outcome Measures
Name Time Method -Diagnostic yield (per case) of samples acquired with ROSE vs. without ROSE<br /><br>-Sensitivity, specificity, negative predictive value and positive predictive value of number of needle passes with ROSE vs. without ROSE<br /><br>-Result of evaluation of each sample by the cytotechnician on-site vs. that of the cytopathologist<br /><br>-Number of needle passes required according to the cytotechnician on-site vs. that of the cytopathologist<br /><br>-Procedural time of EUS-FNA with ROSE vs. without ROSE<br /><br>-Number and nature of complications of EUS-FNA with ROSE vs. without ROSE<br /><br>-Costs of EUS-FNA with ROSE vs. without ROSE