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Completed

NCT Number: NCT05226572

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastrointestinal Unit, University of Bologna/Hospital of Imola

Bologna, 40026, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic ultrasound-guided fine needle biopsy

Diagnostic Test

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

Primary outcomes

  1. Diagnostic yield (%) of repeated EUS-fine needle biopsy of pancreatic masses after previous non-diagnostic or inconclusive results

    Time frame: 5 years

    Outcome was measured as percentage (%)

Secondary outcomes

  1. 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.

    Time frame: 5 years

    Outcome was measured as percentage (%)

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Acronym: REuBio

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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