Rapid on-site evaluation (ROSE) vs. randomly collected samples from mediastinal and abdominal lymph nodes obtained by endoscopic ultrasound-guided fine-needle-aspiratio
Completed
- Conditions
- Enlarged lymph nodeslymphadenopathy10017990
- Registration Number
- NL-OMON45053
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 244
Inclusion Criteria
>=18 years old
Scheduled to undergo endoscopic ultrasound (EUS) with fine-needle aspiration (FNA) of a lymph node in either the mediastinum or the abdomen
Written informed consent
Exclusion Criteria
Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study
Coagulopathy (INR>1.5, platelets<50.000/mm3) which has not been corrected prior to the procedure
Pregnancy
Previous participation in this trial
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameter is the percentage of cases in which the cytopathologist<br /><br>can make a diagnosis on the contents of the lymph node, based on the EUS-FNA<br /><br>samples of the lymph node. (=diagnostic yield)</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Diagnostic accuracy<br /><br>-Sensitivity, specificity, negative predictive value and positive predictive<br /><br>value of a certain number of needle passes in both groups.<br /><br>-Judgment of the cytotechnician on-site and the cytopathologist of each sample<br /><br>-Number of needle passes required per case according to the cytotechnician<br /><br>on-site and according to the cytopathologist in both groups.<br /><br>-Time required in both groups.<br /><br>-Cost-effectivity of both approaches.<br /><br>-Number and nature of complications in both groups.</p><br>