Pancreas Cancer Clinical Trial
Official title:
Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results - The REuBio Study
The primary aim of REuBio study is to evaluate the diagnostic accuracy of repeated endoscopic ultrasound-guided fine needle biopsy after a previous non-diagnostic or inconclusive EUS-guided sampling of solid pancreatic lesions.
Endoscopic ultrasound-guided fine needles biopsy (EUS-FNB) represents the gold standard method for the diagnosis of solid pancreatic lesions (SPLs), even if a non-negligible risk of false-negative or inconclusive results still exists. In such cases, major guidelines recommend repeating EUS-guided tissue sampling. Nevertheless, this recommendation is not based on high-quality evidence and little is known about the performance of repeated EUS-FNB (rEUS-FNB). The primary aim of this study is to evaluate the diagnostic accuracy of rEUS-FNB after a previous non-diagnostic or inconclusive EUS-guided sampling of SPLs. The secondary aims of this study are to evaluate rEUS-FNB sensitivity, specificity, positive predictive value, negative predictive value, specimen adequacy, Bethesda classification, adverse events incidence and factors that influenced rEUS-FNB performance. ;
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