Status:
COMPLETED
Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results
Lead Sponsor:
University of Bologna
Conditions:
Pancreatic Adenocarcinoma
Pancreas Cancer
Eligibility:
All Genders
18-90 years
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 o...
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 ...
Eligibility Criteria
Inclusion
- Age \>18 years old
- Solid pancreatic mass
- Previous non diagnostic or inconclusive EUS-tissue aquisition
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 23 2022
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT05226572
Start Date
July 1 2017
End Date
May 23 2022
Last Update
November 8 2022
Active Locations (1)
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1
Gastrointestinal Unit, University of Bologna/Hospital of Imola
Bologna, Italy, 40026