Comparison of the Diagnostic Performance of Newly Designed 21-Gauge and Standard 22-Gauge Aspiration Needles in Patients with Solid Pancreatic Masses
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Although endoscopic ultrasound-guided fine needle aspiration (EUS–FNA) has been widely used for the diagnosis of pancreatic tumors, the ability to obtain adequate pancreatic tumor tissue needs to be improved.
This study was performed to compare a newly designed 21-gauge needle (EUS Sonopsy CY; Hakko Medical, Nagano, Japan) and a standard 22-gauge needle for tissue sampling of solid pancreatic masses.
Consecutive patients with solid pancreatic masses who underwent EUS–FNA with either the EUS Sonopsy CY or the 22-gauge needle from June 2014 to December 2016 were enrolled. The primary outcome was comparison of the diagnostic yield of the FNA samples. The secondary outcomes were comparison of technical success, diagnostic ability for malignancy, and complications.
A total of 93 patients (40.9% female; mean age, 70.1 years) underwent EUS–FNA with the EUS Sonopsy CY (n = 47) or the standard 22-gauge needle (n = 46). The technical success rate was 100% in both groups, and the overall diagnostic accuracy for malignancy was similar between the groups (100% in the EUS Sonopsy CY group vs. 95.7% in the 22-gauge needle group, P = 0.242). Nevertheless, the EUS Sonopsy CY resulted in significantly higher scores for cellularity (P = 0.006) and lower scores for blood contamination (P < 0.001). The procedure-related complication rate was comparable between the groups (P = 0.148).
The EUS Sonopsy CY provided higher-quality specimens for histological evaluation in terms of both sample cellularity and blood contamination for the diagnosis of solid pancreatic masses.
The study was registered in a clinical trial registry, No. UMIN000032598
KeywordsEndoscopic ultrasound EUS EUS–FNA Fine needle aspiration Pancreatic mass
YY, MK, and UY designed the research; IM, IT, IH, NY, and AT collected the data and contributed to data analysis and interpretation; YY, UY, HK, MK, and MH performed EUS and EUS-guided FNA. AH and OK performed the pathologic evaluation; TM and CY contributed to the statistical analysis; MK, YT, and YY wrote the paper. WT critically revised the manuscript for important intellectual content. KM contributed to study conception and supervised the study. All authors discussed the results on article and contributed to final approval.
Compliance with ethical standards
Conflict of interest
Minaga K., Yoshikawa T., Yamashita Y., Akamatsu H., Ikenouchi M., Ishii T., Matsumoto H., Iwagami H., Nakatani Y., Hatamaru K., Takenaka M., Akamatsu T., Uenoyama Y., Watanabe T., Ono K., and Chiba Y. have no conflict of interest or financial ties to disclose. Kudo M. discloses grants from Chugai Pharmaceutical, Otsuka Pharmaceutical, Takeda Pharmaceutical, Taiho Pharma, Sumitomo Dainippon Pharma, Daiichi Sankyo Pharma, MSD, AbbVie INC., Medico’s Hirata INC., Astellas Pharma, and Bristol-Myers Squibb and advisory consulting for Kowa Pharmaceutical, MSD, Bayer Pharma, Ono Pharmaceutical, and Eisai Pharma.
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