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

November 7, 2022 updated by: Pietro Fusaroli, University of Bologna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

462

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40026
        • Gastrointestinal Unit, University of Bologna/Hospital of Imola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Pietro Fusaroli, Professor, University of Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

May 23, 2022

Study Completion (Actual)

May 23, 2022

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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