Comparison of the diagnostic performance of 2 core biopsy needles for EUS-guided tissue acquisition from solid pancreatic lesions.

A new core biopsy needle with a novel tip, opposing bevel, and sheath design has recently been introduced for EUS-guided fine-needle biopsy (FNB). The diagnostic utility of this needle for differentiating solid pancreatic masses is currently unknown. The aim of this study was to compare the diagnostic performance and yield for tissue acquisition from solid pancreatic lesions of the opposing bevel needle with those of a reverse bevel EUS-FNB needle. Consecutive patients with solid pancreatic masses undergoing EUS-FNB using the opposing bevel (n = 101) and the reverse bevel (n = 100) core biopsy needles were included in the study. Final diagnosis was based on positive histology or at least 12 months of follow-up in cases with a negative biopsy. The primary outcome was the diagnostic performance of the 2 needles for malignant pancreatic masses. A secondary outcome was the diagnostic yield. Compared with the reverse bevel needle, using strict criteria the opposing bevel needle provided significantly higher sensitivity (71.1% vs 90.1%; P = .0006) and overall accuracy (74% vs 92%; I = 0.0006) for discriminating malignant from benign solid pancreatic masses. The proportion of samples classified as adequate for histologic analysis was 87% for the reverse bevel needle versus 99% for the opposing bevel needle (p = 0.002) Multivariate analysis controlling the needle gauge and site did not show any significant difference in accuracy and sensitivity between the 2 groups. There were no adverse events in either group. In this first, large, single-center preliminary cohort study, an EUS core biopsy needle with a novel tip, opposing bevel, and sheath design afforded substantially superior tissue yield and diagnostic performance compared with a reverse-bevel needle. If replicated by randomized controlled trials, our findings suggest that similarly designed needles could become the standard of care for EUS-guided tissue acquisition from solid pancreatic masses.

Nayar MK ，Paranandi B ，Dawwas MF ，Leeds JS ，Darne A ，Haugk B ，Majumdar D ，Ahmed MM ，Oppong KW ... -  《-》

EUS-guided reverse bevel fine-needle biopsy sampling and open tip fine-needle aspiration in solid pancreatic lesions - a prospective, comparative study.

Hedenström P ，Demir A ，Khodakaram K ，Nilsson O ，Sadik R ... -  《-》

Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study.

An endoscopic ultrasound (EUS)-guided fine needle biopsy (EUS-FNB) device using a core biopsy needle was developed to improve diagnostic accuracy by simultaneously obtaining cytological aspirates and histological core samples. We prospectively compared the diagnostic accuracy of EUS-FNB with standard EUS-guided fine needle aspiration (EUS-FNA) in patients with solid pancreatic masses. Between January 2012 and May 2013, consecutive patients with solid pancreatic masses were prospectively enrolled and randomized to undergo EUS-FNB using a core biopsy needle or EUS-FNA using a standard aspiration needle at a single tertiary center. The specimen was analyzed by onsite cytology, Papanicolaou-stain cytology, and histology. The main outcome measure was diagnostic accuracy for malignancy. The secondary outcome measures were: the median number of passes required to establish a diagnosis, the proportion of patients in whom the diagnosis was established with each pass, and complication rates. The overall accuracy of combining onsite cytology with Papanicolaou-stain cytology and histology was not significantly different for the FNB (n = 58) and FNA (n = 58) groups (98.3 % [95 %CI 94.9 % - 100 %] vs. 94.8 % [95 %CI 91.9 % - 100 %]; P = 0.671). Compared with FNA, FNB required a significantly lower median number of needle passes to establish a diagnosis (1.0 vs. 2.0; P < 0.001). On subgroup analysis of 111 patients with malignant lesions, the proportion of patients in whom malignancy was diagnosed on the first pass was significantly greater in the FNB group (72.7 % vs. 37.5 %; P < 0.001). The overall accuracy of FNB and FNA in patients with solid pancreatic masses was comparable; however, fewer passes were required to establish the diagnosis of malignancy using FNB.This study was registered on the UMIN Clinical Trial Registry (UMIN000014057).

Lee YN ，Moon JH ，Kim HK ，Choi HJ ，Choi MH ，Kim DC ，Lee TH ，Cha SW ，Cho YD ，Park SH ... -  《-》

Endoscopic ultrasound-guided sampling of solid pancreatic masses: 22-gauge aspiration versus 25-gauge biopsy needles.

Yang MJ ，Yim H ，Hwang JC ，Lee D ，Kim YB ，Lim SG ，Kim SS ，Kang JK ，Yoo BM ，Kim JH ... -  《BMC GASTROENTEROLOGY》

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

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. 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. 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). 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.).

van Riet PA ，Larghi A ，Attili F ，Rindi G ，Nguyen NQ ，Ruszkiewicz A ，Kitano M ，Chikugo T ，Aslanian H ，Farrell J ，Robert M ，Adeniran A ，Van Der Merwe S ，Roskams T ，Chang K ，Lin F ，Lee JG ，Arcidiacono PG ，Petrone M ，Doglioni C ，Iglesias-Garcia J ，Abdulkader I ，Giovannini M ，Bories E ，Poizat F ，Santo E ，Scapa E ，Marmor S ，Bucobo JC ，Buscaglia JM ，Heimann A ，Wu M ，Baldaque-Silva F ，Moro CF ，Erler NS ，Biermann K ，Poley JW ，Cahen DL ，Bruno MJ ... -  《-》