NCT05226572

Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results

Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results - The REuBio Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 462 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Adenocarcinoma
• Pancreas Cancer
• Pancreas Metastases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	endoscopic ultrasound-guided fine needle biopsy	repeated endoscopic ultrasound-guided fine needle-biopsy after a previous non diagnostic or incoclusive endoscopic ultrasound-guided tissue aquisition for pancreatic solid lesions.

Timeline

• Start date: 2017-07-01
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2022-02-07
• Last updated: 2022-11-08

Locations

1 site across 1 country: Italy