Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study
- Abstract
- BACKGROUND AND STUDY AIMS: 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. PATIENTS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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).
- All Author(s)
- Y. N. Lee
; J. H. Moon
; H. K. Kim
; H. J. Choi
; M. H. Choi
; D. C. Kim
; T. H. Lee
; S. W. Cha
; Y. D. Cho
; S. H. Park
- Issued Date
- 2014
- Type
- Article
- Keyword
- Aged; Biopsy, Large-Core Needle/*instrumentation; Endoscopic Ultrasound-Guided Fine Needle Aspiration/*instrumentation; Equipment Design; Female; Follow-Up Studies; Humans; Male; Middle Aged; *Needles; Pancreatic Neoplasms/*diagnosis; Prospective Studies
- ISSN
- 0013-726x
- Citation Title
- Endoscopy
- Citation Volume
- 46
- Citation Number
- 12
- Citation Start Page
- 1056
- Citation End Page
- 1062
- Language(ISO)
- eng
- DOI
- 10.1055/s-0034-1377558
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/2341
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