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

Pancreas Cancer Clinical Trial

— REuBio  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05226572
• Other study ID #: IMO-01
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: May 23, 2022

Study information

• Verified date: November 2022
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreas Metastases
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Italy	Gastrointestinal Unit, University of Bologna/Hospital of Imola	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Outcome was measured as percentage (%)	5 years