The hypothesis is that rapid on-site evaluation increases diagnostic accuracy of EUS-FNA aof lymph nodes
ID
Bron
Verkorte titel
Aandoening
lymphadenopathy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
the percentage of cases in which the local cytopathologist correctly diagnosed the lymph node, based on the EUS-FNA samples of the lymph node
Achtergrond van het onderzoek
Endoscopic 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.
Doel van het onderzoek
The hypothesis is that rapid on-site evaluation increases diagnostic accuracy of EUS-FNA aof lymph nodes
Onderzoeksopzet
Baseline: patient characteristics
1 week after procedure: (severe) adverse events
1 month after procedure: (severe) adverse events
6 months after procedure: Final diagnosis is determined
Onderzoeksproduct en/of interventie
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 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.
Algemeen / deelnemers
P.O. box 85500
University Medical Center Utrecht
Department of Gastroenterology & Hepatology
Room F02.618
W.F.W. Kappelle
Utrecht 3508 GA
The Netherlands
+31 (0)88 5750724
w.f.w.kappelle@umcutrecht.nl
Wetenschappers
P.O. box 85500
University Medical Center Utrecht
Department of Gastroenterology & Hepatology
Room F02.618
W.F.W. Kappelle
Utrecht 3508 GA
The Netherlands
+31 (0)88 5750724
w.f.w.kappelle@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-≥18 years old
-EUS with FNA of a lymph node in either the mediastinum or abdomen
-Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL4748 |
NTR-old | NTR4876 |
Ander register | Ethical committee Utrecht : 13-455 |