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

Completed

• Conditions: Pancreas Cancer; Pancreatic Adenocarcinoma; Pancreas Metastases

• Registration Number: NCT05226572
• Lead Sponsor: University of Bologna

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.

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 Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-07
• Primary Completion: 2022-05-23
• Study Completion: 2022-05-23
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic yield (%) of repeated EUS-fine needle biopsy of pancreatic masses after previous non-diagnostic or inconclusive results	5 years	Outcome was measured as percentage (%)

Secondary Outcome Measures

Name	Time	Method
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	Outcome was measured as percentage (%)

Trial Locations

Locations (1)

Gastrointestinal Unit, University of Bologna/Hospital of Imola; 🇮🇹 Bologna, Italy