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

NCT05226572 | Completed

• 1 other identifier: IMO-01
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma; Pancreas Cancer; Pancreas Metastases

Keywords

Endoscopic Ultrasound; EUS-FNB; Solid Pancreatic lesion

Outcome Measures

Primary Outcomes (1)

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

  Outcome was measured as percentage (%)

  5 years

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.

  5 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \>18 years old
• Solid pancreatic mass
• Previous non diagnostic or inconclusive EUS-tissue aquisition

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Gastrointestinal Unit, University of Bologna/Hospital of Imola

Bologna, 40026, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Pietro Fusaroli, Professor

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 7, 2022
• Study Start: July 1, 2017
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

IT (1)