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Gastrointest Endosc. 2019 Feb;89(2):329-339. doi: 10.1016/j.gie.2018.10.026. Epub 2018 Oct 24.

A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device.

Author information

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.

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.).

PMID:
30367877
DOI:
10.1016/j.gie.2018.10.026
[Indexed for MEDLINE]

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