Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

ProControl, MediGlobe

TopGain, Medi-Globe

Bojan Kovacevic

Bojan Kovacevic, MD

The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.

Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs

Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions

Comparison of median number of tissue micro-fragments

Comparison of total diagnostic tissue area in um2

Comparison of total total tissue area in um2

diagnostic yield - defined by percentage of diagnostic samples in each group

Sensitivity and specificity, where final diagnosis is either established by subsequent histopathological confirmation or other evidence (clinical, radiological) of malignant disease at a minimum of 12 months of follow-up

Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy

Percentage of samples where NGS analysis was successful

Gastro Unit, Endoscopy Section, Hvidovre Hospital, Denmark

Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania

Endoscopy Unit, Odense Hospital, Denmark

Peter Vilmann MD, DSc, HC, FASGE

Professor

Symptoms and General Pathology

Adenocarcinoma

Neoplasm Metastasis

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

endoscopic ultrasound-guided fine needle biopsy

Pietro Fusaroli, Professor

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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs	NCT04687410	Pancreas Neopla... Pancreas Cancer	ProControl, Med... TopGain, Medi-G...	18 Years -	Herlev Hospital
Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results	NCT05226572	Pancreatic Aden... Pancreas Cancer Pancreas Metast...	endoscopic ultr...	18 Years - 90 Years	University of Bologna
Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results	NCT05226572	Pancreatic Aden... Pancreas Cancer Pancreas Metast...	endoscopic ultr...	18 Years - 90 Years	University of Bologna
Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results	NCT05226572	Pancreatic Aden... Pancreas Cancer Pancreas Metast...	endoscopic ultr...	18 Years - 90 Years	University of Bologna

Spots Global Cancer Trial Database for solid pancreatic lesion