lymphadenopathy
Conditions
Interventions
patients who gave informed consent in who EUS-FNA of a mediastinal/abdominal lymph node is performed are randomized to rapid on-site evaluation after each pass or to 'Random', in which case 5 passes a
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: -≥18 years old -EUS with FNA of a lymph node in either the mediastinum or abdomen -Written informed consent
Exclusion criteria
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 -Pregnancy -Previous participation in the ROSE study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| -Diagnostic yield (per case) of samples acquired with ROSE vs. without ROSE -Sensitivity, specificity, negative predictive value and positive predictive value of number of needle passes with ROSE vs. without ROSE -Result of evaluation of each sample by the cytotechnician on-site vs. that of the cytopathologist -Number of needle passes required according to the cytotechnician on-site vs. that of the cytopathologist -Procedural time of EUS-FNA with ROSE vs. without ROSE -Number and nature of complications of EUS-FNA with ROSE vs. without ROSE -Costs of EUS-FNA with ROSE vs. without ROSE | — |
Primary
| Measure | Time frame |
|---|---|
| the percentage of cases in which the local cytopathologist correctly diagnosed the lymph node, based on the EUS-FNA samples of the lymph node | — |
Contacts
Public ContactW.F.W. Kappelle
P.O. box 85500 University Medical Center Utrecht Department of Gastroenterology & Hepatology Room F02.618
Outcome results
None listed