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The clinical benefit of thin layer preparations with endoscopic ultrasound-guided fine-needle aspiration of masses: a prospective cohort study


- candidate number20868
- NTR NumberNTR4889
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2014
- Secondary IDs14-496 Ethical committee Utrecht
- Public TitleThe clinical benefit of thin layer preparations with endoscopic ultrasound-guided fine-needle aspiration of masses: a prospective cohort study
- Scientific TitleThe clinical benefit of thin layer preparations obtained with endoscopic ultrasound-guided fine-needle aspiration of masses: a prospective cohort study
- ACRONYMThe Cytolyt study
- hypothesisWe hypothesize that diagnostic accuracy increases when, apart from cytologic samples, material is aspirated for thin layer preparation in endoscopic-ultrasound guided fine needle aspiration (EUS-FNA) of masses.
- Healt Condition(s) or Problem(s) studiedEndoscopic ultrasound (EUS)
- Inclusion criteria-EUS-FNA of a mediastinal/ abdominal mass
-Written informed consent
- Exclusion criteria-Failure to acquire material during EUS-FNA.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 3-nov-2014
- planned closingdate3-nov-2015
- Target number of participants100
- InterventionsNo intervention is part of this study
- Primary outcomeDiagnostic accuracy of EUS-FNA of masses with and without the thin layer preparation taken into account
- Secondary outcomeDiagnostic adequacy
Cost-effectivity of thin layer preparation
Type of benefit from thin layer preparation
- TimepointsBaseline: Patient characteristics
6 months after EUSFNA: final diagnosis
- Trial web site
- statusplanned
- 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 summaryIn endoscopic ultrasound-with fine-needle aspiration (EUS-FNA) of masses, inserting part of the aspirate (or a separate aspirate) into CytoLyt is standard practice in our hospital, in addition to cytology slides. A thin layer preparation of this sample is then done in the pathology laboratory. It is not clear what the added value of such thin-layer preparation with CytoLyt is. Is This study is designed to examine the added value. In a 100 patients who undergo EUS-FNA of a mass, informed consent is asked. After the procedure, material is reviewed at a later time by two dedicated pathologists; first, only the cytology slides of a patient are reviewed, and a diagnosis is made if possible. Thus, a situation is simulated in which no thin-layer preparation is available. After this, the thin-layer preparation is given to the pathologists and all the material is again reviewed and a diagnosis is made if possible. samples are compared to the golden standard; surgical resection, histology or six months clinical follow-up. The difference between assessment with and without thin-layer preparations with regard to diagnostic yield and diagnostic accuracy is then calculated.
- Main changes (audit trail)
- RECORD3-nov-2014 - 16-dec-2014


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