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


Background and Aims: Several studies have compared EUS fine-needle aspiration (FNA) with biopsy (FNB) needles, but none has 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). 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=0.043), without differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histological yield (77% vs 44%, p<0.001), accuracy for malignancy (87% vs 78%, p=0.002) and Bethesda classification (82% vs 72%, p=0.002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (OR, 3.53; 95% CI, 1.55-8.56; p=0.004), and did not differ between centers (p=0.836).
Conclusion: The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histological yield and diagnostic accuracy. This benefit was irrespective of the indication and consistent among participating centers, supporting the general applicability of our findings.

Gastrointestinal Endoscopy, 2019, 89 (2), 329 – 339