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Rapid on-site evaluation vs. randomly collected samples from mediastinal and abdominal lymph nodes obtained by endoscopic ultrasound-guided fine-needle-aspiration


- candidate number20861
- NTR NumberNTR4876
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2014
- Secondary IDs13-455 Ethical committee Utrecht
- Public TitleRapid on-site evaluation vs. randomly collected samples from mediastinal and abdominal lymph nodes obtained by endoscopic ultrasound-guided fine-needle-aspiration
- Scientific TitleRapid on-site evaluation vs. randomly collected samples from mediastinal and abdominal lymph nodes obtained by endoscopic ultrasound-guided fine-needle-aspiration
- ACRONYMROSE-study
- hypothesisThe hypothesis is that rapid on-site evaluation increases diagnostic accuracy of EUS-FNA aof lymph nodes
- Healt Condition(s) or Problem(s) studiedLymphadenopathy
- Inclusion criteria-≥18 years old
-EUS with FNA of a lymph node in either the mediastinum or abdomen
-Written informed consent
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-feb-2014
- planned closingdate1-nov-2015
- Target number of participants234
- Interventionspatients 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 are done before the cyto-technician informs the endosonographer whether the samples are adequate. This way, a situation in which the technician is not in the room is simulated. At a later time, all samples are reviewed by a dedicated pathologist.
- Primary outcomethe 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-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
- TimepointsBaseline: patient characteristics
1 week after procedure: (severe) adverse events
1 month after procedure: (severe) adverse events
6 months after procedure: Final diagnosis is determined
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD W.F.W. Kappelle
- CONTACT for SCIENTIFIC QUERIESMD W.F.W. Kappelle
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summaryEndoscopic ultrasound guided fine-needle aspiration (EUS-FNA) of lymph nodes is an important diagnostic instrument for an increasing number of disorders. A representative sample of the lymph node is essential for making a diagnosis. Therefore, there is an ongoing ambition to improve the diagnostic accuracy of EUS-FNA. Rapid on-site evaluation (ROSE), with a cytotechnician or cytopathologist on-site, is an option to achieve this. However, the additional value of ROSE with regard to lymph nodes has never been studied in a randomized controlled trial. We hypothesize that ROSE increases the diagnostic accuracy of EUS-FNA of mediastinal and abdominal lymph nodes when compared to random “blind” FNA.
- Main changes (audit trail)
- RECORD3-nov-2014 - 1-dec-2014


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