Clinical trial NCT05226572: Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results
Official title: Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results - The REuBio Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Adenocarcinoma
Pancreas Cancer
Pancreas Metastases
Keywords: Endoscopic Ultrasound
EUS-FNB
Solid Pancreatic lesion
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A multicenter retrospective observational study enrolling all the consecutive patients who underwent a repeated EUS-guided tissue sampling for solid pancreatic masses with an EUS-FNB needle, after previous non-diagnostic or inconclusive result.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield (%) of repeated EUS-fine needle biopsy of pancreatic masses after previous non-diagnostic or inconclusive results
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Gastrointestinal Unit, University of Bologna/Hospital of Imola
Study officials:
affiliation: University of Bologna
name: Pietro Fusaroli, Professor
role: PRINCIPAL_INVESTIGATOR
References: