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A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device - 21/01/19

Doi : 10.1016/j.gie.2018.10.026 
Priscilla A. van Riet, MD 1, ⁎, Alberto Larghi, MD, PhD 2, Fabia Attili, MD, PhD 2, Guido Rindi, MD, PhD 3, Nam Quoc Nguyen, MD, PhD 4, Andrew Ruszkiewicz 5 : prof., Masayuki Kitano 6 : prof., Takaaki Chikugo, MD, PhD 7, Harry Aslanian, MD, PhD 8, James Farrell, MD, PhD 8, Marie Robert, MD, PhD 9, Adebowale Adeniran, MD 9, Schalk Van Der Merwe 10 : prof., Tania Roskams, prof. 11, Kenneth Chang 12 : prof., Fritz Lin 13 : prof., John G. Lee, MD 12, Paolo Giorgio Arcidiacono, MD, PhD 14, Mariachiara Petrone, MD 14, Claudio Doglioni 15 : prof., Julio Iglesias-Garcia, MD, PhD 16, Ihab Abdulkader, MD, PhD 17, Marc Giovannini 18 : prof., Erwan Bories, MD 18, Flora Poizat, MD 19, Erwin Santo, MD, PhD 20, Erez Scapa, MD 20, Silvia Marmor, MD 21, Juan Carlos Bucobo, MD 22, Jonathan M. Buscaglia, MD 22, Alan Heimann, MD 23, Maoxin Wu, MD 23, Francisco Baldaque-Silva, MD, PhD 24, Carlos Fernández Moro, MD 25, Nicole S. Erler, PhD 26, Katharina Biermann, MD, PhD 27, Jan-Werner Poley, MD, PhD 1, Djuna L. Cahen, MD, PhD 1, Marco J. Bruno 1 : prof.
1 Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands 
2 Department of Endoscopy, Catholic University Rome, Rome, Italy 
3 Department of Pathology, Catholic University Rome, Rome, Italy 
4 Department of Endoscopy, Royal Adelaide Hospital, Adelaide, Australia 
5 Department of Pathology, Royal Adelaide Hospital, Adelaide, Australia 
6 Department of Endoscopy, Kinki University, Osaka-Sayama, Japan 
7 Department of Pathology, Kinki University, Osaka-Sayama, Japan 
8 Department of Endoscopy, Yale University School of Medicine, New Haven, Connecticut, USA 
9 Department of Pathology, Yale University School of Medicine, New Haven, Connecticut, USA 
10 Department of Endoscopy, University Hospital Leuven, Leuven, Belgium 
11 Department of Pathology, University Hospital Leuven, Leuven, Belgium 
12 Department of Endoscopy, University of California, Irvine, California, USA 
13 Department of Pathology, University of California, Irvine, California, USA 
14 Department of Endoscopy, Vita Salute San Raffaele University, Milan, Italy 
15 Department of Pathology, Vita Salute San Raffaele University, Milan, Italy 
16 Department of Endoscopy, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain 
17 Department of Pathology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain 
18 Department of Endoscopy, Institut Paoli-Calmettes, Marseilles, France 
19 Department of Pathology, Institut Paoli-Calmettes, Marseilles, France 
20 Department of Endoscopy, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel 
21 Department of Pathology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel 
22 Department of Endoscopy, Stony Brook University Hospital, Stony Brook, New York, USA 
23 Department of Pathology, Stony Brook University Hospital, Stony Brook, New York, USA 
24 Department of Upper GI Diseases, Unit of Gastrointestinal Endoscopy, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden 
25 Department of Clinical Pathology/Cytology, Karolinska University Hospital, Stockholm, Sweden 
26 Department of Biostatistics, Erasmus MC University Medical Center Rotterdam, the Netherlands 
27 Department of Pathology, Erasmus MC University Medical Center Rotterdam, the Netherlands 

∗Reprint requests: Priscilla Anita van Riet, MD, Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, PO Box 2040, 3015 CE Rotterdam, the Netherlands.Department of Gastroenterology and HepatologyErasmus MC University Medical Center RotterdamPO Box 2040RotterdamCE3015the Netherlands

Abstract

Background and Aims

Several studies have compared EUS-guided FNA with fine-needle biopsy (FNB), but none have proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle.

Methods

Consecutive patients with a solid lesion were randomized in this international multicenter study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). The primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification (non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample quality were also assessed. Multivariable and supplementary analyses were performed to adjust for confounders.

Results

A total of 608 patients were allocated to FNA (n = 306) or FNB (n = 302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (P = .043), with no differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histologic yield (77% vs 44%, P < .001), accuracy for malignancy (87% vs 78%, P = .002) and Bethesda classification (82% vs 72%, P = .002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (odds ratio, 3.53; 95% confidence interval, 1.55-8.56; P = .004), and did not differ among centers (P = .836).

Conclusion

The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histologic yield and diagnostic accuracy. This benefit was irrespective of the indication and was consistent among participating centers, supporting the general applicability of our findings. (Clinical trial registration number: NCT02167074.)

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : FNB, ROSE


Mappa


 If you would like to chat with an author of this article, you may contact Dr van Riet at p.vanriet@erasmusmc.nl.
 DISCLOSURE: Dr van Riet was a consultant for Cook Medical Devices during United European Gastroenterology Week in 2016. Dr Robert has participated in Speakers Bureau (Merck), Beyond Celiac Foundation, and a clinical trial on pancreas cancer (Bayer). Dr Chang is a consultant for and has received educational grants from Cook Medical and Olympus. Dr Bories is a consultant for Cook Medical and Pentax. Dr Poley is a consultant for and has received speaker's fees and travel arrangements from Cook Medical, Boston Scientific, and Pentax. Dr Baldaque-Silva is a consultant for Boston Scientific and has received travel reimbursement from Olympus. Dr Bruno is a consultant and lectures for Cook Medical and a consultant and lectures for Boston Scientific.
 See CME Section; p. 383.


© 2019  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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Vol 89 - N° 2

P. 329-339 - febbraio 2019 Ritorno al numero
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