EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial
Background: Rapid on-site evaluation (ROSE) of cytological specimensacquired with EUS-guided fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a definitive diagnosis in patients with pancreatic solid masses. Recently, needles with high histological yield have been developed for EUS-guided fine needle biopsy (EUS-FNB), with which the need for ROSE can be potentially overcome. Aims: The primary aim is to compare the diagnostic accuracy of EUS-FNB with or without ROSE. The main endpoint will be measured against the gold standard diagnosis (surgical pathology whenever available or diagnostic work-up in agreement with a clinical course of at least six months). Secondary endpoints include: (a) safety; (b) presence of tissue core; (c) quality of specimens; (d) time of the sampling procedure. Reliability of macroscopic on-site evaluation (MOSE) by endosonographers will be also assessed. Methods: FROSENOR is an international randomized non-inferiority ongoing study at sixteen centers in four continents. Eight hundred patients will be randomized in two arms (EUS-FNB + ROSE vs. EUSFNB alone) and outcomes compared. Sample size has been calculated in order to demonstrate the noninferiority of FNB alone. Randomization and data collection will be performed online. Discussion: This study will ascertain if ROSE is still needed when performing EUS-FNB of solid pancreatic lesions.
|Keywords||Diagnostic accuracy, Endoscopic ultrasound, Pancreatic cancer|
|Persistent URL||dx.doi.org/10.1016/j.dld.2019.03.008, hdl.handle.net/1765/116822|
|Journal||Digestive and Liver Disease|
Crino, S.F., Manfrin, E., Scarpa, A, Baldaque-Silva, F., Carrara, S., De Nucci, G., … Larghi, A. (2019). EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial. Digestive and Liver Disease, 51(6), 901–906. doi:10.1016/j.dld.2019.03.008