Pancreas Cancer, Pancreas Metastases, Pancreatic Adenocarcinoma
Conditions
Keywords
Endoscopic Ultrasound, EUS-FNB, Solid Pancreatic lesion
Brief 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.
Interventions
DIAGNOSTIC_TESTendoscopic 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.
Sponsors
University of Bologna
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age \>18 years old * Solid pancreatic mass * Previous non diagnostic or inconclusive EUS-tissue aquisition
Exclusion criteria
* age \< 18 years old * pancreatic mass with a predominantly cystic component * previous pancreatic tissue acquisition was not performed under EUS-guidance (e.g. percutaneous sampling under abdominal ultrasound-guidance) * repetition of pancreatic tissue sampling, after an inconclusive or non-diagnostic result, obtained by other methods than EUS-FNB, such as EUS-FNA or surgery or percutaneous sampling. * patients with anatomic alterations or hematologic instability (including presence of severe blood clotting disorders) were excluded. * rEUS-FNB of an extra-pancreatic mass
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield (%) of repeated EUS-fine needle biopsy of pancreatic masses after previous non-diagnostic or inconclusive results | 5 years | Outcome was measured as percentage (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity (%), specificity(%), positive predictive value(%), negative predictive value(%), specimen adequacy(%), Bethesda classification, adverse events incidence (%) and factors that influenced repeated EUS-fine needle biopsy performance. | 5 years | Outcome was measured as percentage (%) |
Countries
Italy
Outcome results
None listed