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Randomized Controlled Trial Observational Study
Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study.
- Yun Nah Lee, Jong Ho Moon, Hee Kyung Kim, Hyun Jong Choi, Moon Han Choi, Dong Choon Kim, Tae Hoon Lee, Sang-Woo Cha, Young Deok Cho, and Sang-Heum Park.
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
- Endoscopy. 2014 Dec 1; 46 (12): 1056-62.
Background And Study AimsAn 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 MethodsBetween 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.ResultsThe 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).ConclusionsThe 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).© Georg Thieme Verlag KG Stuttgart · New York.
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