No registrations found.
ID
Source
Brief title
Health condition
EUS-FNA of a mass
endo-echografie van een massa
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of EUS-FNA of masses with and without the thin layer preparation taken into account
Secondary outcome
Diagnostic adequacy
Cost-effectivity of thin layer preparation
Type of benefit from thin layer preparation
Background summary
In 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.
Study objective
We 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.
Study design
Baseline: Patient characteristics
6 months after EUSFNA: final diagnosis
Intervention
No intervention is part of this study
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
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
Inclusion criteria
-EUS-FNA of a mediastinal/ abdominal mass
-Written informed consent
Exclusion criteria
-Failure to acquire material during EUS-FNA.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4761 |
NTR-old | NTR4889 |
Other | Ethical committee Utrecht : 14-496 |