Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results
NCT ID: NCT05226572
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
462 participants
OBSERVATIONAL
2017-07-01
2022-05-23
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Solid pancreatic mass
* Previous non diagnostic or inconclusive EUS-tissue aquisition
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University of Bologna
OTHER
Responsible Party
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Pietro Fusaroli
Clinical Professor
Principal Investigators
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Pietro Fusaroli, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Bologna
Locations
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Gastrointestinal Unit, University of Bologna/Hospital of Imola
Bologna, , Italy
Countries
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Other Identifiers
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IMO-01
Identifier Type: -
Identifier Source: org_study_id
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