Fork-tip needle biopsy versus fine-needle aspiration in endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized crossover study

Abstract

Background A novel fork-tip fine-needle biopsy (FNB) needle has recently been introduced for endoscopic ultrasound (EUS)-guided sampling. The aim of this study was to compare the performance of fork-tip FNB histology and standard fine-needle aspiration (FNA) cytology in the diagnosis of solid pancreatic masses.

Methods A randomized crossover study was performed in patients referred for EUS-guided sampling. Three passes were taken with each needle in a randomized order. Only samples reported as diagnostic of malignancy were considered positive. The primary end point was the sensitivity of diagnosis of malignancy. Secondary end points included the amount of sample obtained, ease of diagnosis, duration of tissue sampling, pathologist viewing time, and cost.

Results 108 patients were recruited. Median age was 69 years (range 30 – 87) and 57 were male; 85.2 % had a final diagnosis of malignancy. There were statistically significant differences in sensitivity (82 % [95 % confidence interval (CI) 72 % to 89 %] vs. 71 % [95 %CI 60 % to 80 %]), accuracy (84 % [95 %CI 76 % to 91 %] vs. 75 % [95 %CI 66 % to 83 %]), proportion graded as a straightforward diagnosis (69 % [95 %CI 60 % to 78 %] vs. 51 % [95 %CI 41 % to 61 %]), and median pathology viewing time (188 vs. 332 seconds) (P < 0.001) between FNB and FNA needles, respectively. There was no significant difference in cost between an FNB or FNA strategy.

Conclusion The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.

Publication History

Received: 16 August 2019

Accepted: 21 January 2020

Article published online:
11 March 2020

• References

• 1 Puli SR, Bechtold ML, Buxbaum JL. et al. How good is endoscopic ultrasound-guided fine-needle aspiration in diagnosing the correct etiology for a solid pancreatic mass? a meta-analysis and systematic review. Pancreas 2013; 42: 20-26
• 2 Hewitt MJ, McPhail MJW, Possamai L. et al. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc 2012; 75: 319-331
• 3 Turner BG, Cizginer S, Agarwal D. et al. Diagnosis of pancreatic neoplasia with EUS and FNA: a report of accuracy. Gastrointest Endosc 2010; 71: 91-98
• 4 van Riet PA, Larghi A, Attili F. et al. A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device. Gastrointest Endosc 2019; 89: 329-339
• 5 Kamata K, Kitano M, Yasukawa S. et al. Histologic diagnosis of pancreatic masses using 25-gauge endoscopic ultrasound needles with and without a core trap: a multicenter randomized trial. Endoscopy 2016; 48: 632-638
• 6 Dumonceau J-M, Koessler T, van Hooft JE. et al. Endoscopic ultrasonography-guided fine needle aspiration: relatively low sensitivity in the endosonographer population. World J Gastroenterol 2012; 18: 2357-2363
• 7 Kandel P, Wallace MB. Advanced EUS guided tissue acquisition methods for pancreatic cancer. Cancers (Basel) 2018; 10: 54
• 8 Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy 2016; 48: 339-349
• 9 Facciorusso A, Bajwa HS, Menon K. et al. Comparison between 22G aspiration and 22G biopsy needles for EUS-guided sampling of pancreatic lesions: a meta-analysis. Endosc Ultrasound 2019; DOI: 10.4103/eus.eus_4_19.
• 10 Kandel P, Tranesh G, Nassar A. et al. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case–control study. Gastrointest Endosc 2016; 84: 1034-1039
• 11 DiMaio C, Kolb J, Benias P. et al. Initial experience with a novel EUS-guided core biopsy needle (SharkCore): results of a large North American multicenter study. Endosc Int Open 2016; 4: E974-979
• 12 Nayar MK, Paranandi B, Dawwas MF. et al. Comparison of the diagnostic performance of 2 core biopsy needles for EUS-guided tissue acquisition from solid pancreatic lesions. Gastrointest Endosc 2017; 85: 1017-1024
• 13 Eloubeidi MA, Tamhane A, Varadarajulu S. et al. Frequency of major complications after EUS-guided FNA of solid pancreatic masses: a prospective evaluation. Gastrointest Endosc 2006; 63: 622-629
• 14 Cheng B, Zhang Y, Chen Q. et al. Analysis of fine-needle biopsy vs fine-needle aspiration in diagnosis of pancreatic and abdominal masses: a prospective, multicenter, randomized controlled trial. Clin Gastroenterol Hepatol 2018; 16: 1314-1321
• 15 Vanbiervliet G, Napoléon B, Saint Paul M. et al. Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study. Endoscopy 2014; 46: 1063-1070
• 16 Khan MA, Grimm IS, Ali B. et al. A meta-analysis of endoscopic ultrasound-fine-needle aspiration compared to endoscopic ultrasound-fine-needle biopsy: diagnostic yield and the value of onsite cytopathological assessment. Endosc Int open 2017; 5: E363-E375
• 17 Li H, Li W, Zhou QY. et al. Fine needle biopsy is superior to fine needle aspiration in endoscopic ultrasound guided sampling of pancreatic masses. Medicine (Baltimore) 2018; 97: e0207
• 18 Jovani M, Abidi WM, Lee LS. Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study. Scand J Gastroenterol 2017; 52: 784-787
• 19 Di Leo M, Crinò SF, Bernardoni L. et al. EUS-guided core biopsies of pancreatic solid masses using a new fork-tip needle: a multicenter prospective study. Dig Liver Dis 2019; 51: 1275-1280
• 20 Bang JY, Kirtane S, Krall K. et al. In memoriam: Fine-needle aspiration, birth: Fine-needle biopsy: The changing trend in endoscopic ultrasound-guided tissue acquisition. Dig Endosc 2019; 31: 197-202
• 21 Naveed M, Siddiqui AA, Kowalski TE. et al. A multicenter comparative trial of a novel EUS-guided core biopsy needle (SharkCoreTM) with the 22-gauge needle in patients with solid pancreatic mass lesions. Endosc Ultrasound 2018; 7: 34-40
• 22 Song Z, Trujillo CN, Song H. et al. Endoscopic ultrasound-guided tissue acquisition using fork-tip needle improves histological yield, reduces needle passes, without on-site cytopathological evaluation. J Pancreat Cancer 2018; 4: 75-80
• 23 Bang JY, Hebert-Magee S, Navaneethan U. et al. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc 2018; 87: 1432-1438