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Randomized trial comparing fork-tip and side-fenestrated needles for EUS-guided fine-needle biopsy of solid pancreatic lesions - 21/08/20

Doi : 10.1016/j.gie.2020.05.016 
Stefano Francesco Crinò, MD 1, ⁎, Marco Le Grazie, MD 1, Erminia Manfrin, MD 2, Maria Cristina Conti Bellocchi, MD 1, Laura Bernardoni, MD 1, Anna Granato, MD 1, Francesca Locatelli 3, Alice Parisi, MD 2, Serena Di Stefano, MD 1, Luca Frulloni, MD, PhD 1, Alberto Larghi, MD, PhD 4, Armando Gabbrielli, MD 1
1 Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy 
2 Unit of Pathology, Department of Diagnostics and Public Health, G.B. Rossi University Hospital, Verona, Italy 
3 Unit of Epidemiology and Medical Statistics, Department of Diagnostics and Public Health, G.B. Rossi University Hospital, Verona, Italy 
4 Digestive Endoscopy Unit, Fondazione Policlinico A. Gemelli, IRCCS, Rome, Italy 

∗Reprint requests: Stefano Francesco Crinò, MD, Gastroenterology and Digestive Endoscopy Unit, G. B. Rossi University Hospital, P.le L.A. Scuro 10, Verona 37134, Italy.Gastroenterology and Digestive Endoscopy UnitG. B. Rossi University HospitalP.le L.A. Scuro 10Verona37134Italy

Abstract

Background and Aims

The aim of this study was to compare the performance of EUS-guided fine-needle biopsy using fork-tip or side-fenestrated needles in patients with solid pancreatic lesions.

Methods

A randomized controlled study was conducted in a single academic center on patients who underwent sampling with fork-tip or side-fenestrated 22-gauge or 25-gauge needles. Three passes were performed, each independently evaluated by a blinded pathologist and by endosonographers for macroscopic on-site evaluation (MOSE). The primary outcome was histologic yield; secondary aims were safety, diagnostic yield, sample quality, number of needle passes required to establish a diagnosis, and reliability of MOSE.

Results

One hundred ninety-two patients were enrolled. Both 22-gauge and 25-gauge fork-tip needles retrieved significantly higher rates of histologic samples than side-fenestrated needles (P < .013). Safety and diagnostic accuracy were comparable in the 2 arms, whereas sample quality (tissue integrity and blood contamination) was significantly better in the fork-tip group (P < .0001). The median number of diagnostic passes was lower using fork-tip needles (P = .054). The agreement between MOSE and pathologic evaluation was almost perfect in the fork-tip group and fair in the side-fenestrated group.

Conclusions

Both needles showed equivalent safety and diagnostic accuracy. However, fork-tip needles provided a higher rate of extremely good-quality histologic samples and required fewer needle passes to reach a diagnosis. MOSE is a highly reliable tool when fork-tip needles are used compared with side-fenestrated needles. (Clinical trial registration number: NCT03622229.)

El texto completo de este artículo está disponible en PDF.

Abbreviations : AE, MOSE, NPV, ROSE, SPL


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 If you would like to chat with an author of this article, you may contact Dr Crinò at [email protected].
 DISCLOSURE: Dr Crinò has been a consultant for Boston Scientific. Dr Larghi has been a consultant and received teaching fees from Pentax Medical and has received teaching fees from Boston Scientific and Medtronic. All other authors disclosed no financial relationships.


© 2020  American Society for Gastrointestinal Endoscopy. Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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