Prospective evaluation of 25-gauge Franseen needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses

Abstract

Background and study aims The ideal puncture needle for endoscopic ultrasound (EUS)-guided sampling is maneuverable and easy to puncture with, and can obtain sufficient material in almost one pass. The novel 25-gauge Franseen needle may provide a good balance between maneuverability and sample yield.

Patients and methods Between July 2017 and December 2018, 116 patients with solid pancreatic masses were prospectively enrolled and investigated. We evaluated the diagnostic yield associated with using the 25-gauge Franseen needle for EUS-guided sampling of pancreatic masses.

Results The technical success rate was 100 % (116/116). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for malignancy were 98 % (105/107), 100 % (9/9), 100 % (105/105), 82 % (9/11), and 98 % (114/116), respectively. Cumulative sensitivities for malignancy were 87 % (93/107) on pass 1, 97 % (104/107) on pass 2, and 98 % (105/107) on pass 3, respectively, with no increase in sensitivity after 4 or more. An adequate specimen for histological assessment was obtained in 79 % (92/116) of cases. Multivariate logistic analyses showed that lesion size smaller than 13 mm was a risk factor for failure of obtaining an adequate specimen for histological assessment (P = 0.010)

Conclusions The novel 25-gauge Franseen needle showed excellent diagnostic yield for solid pancreatic masses. However, its ability to obtain an adequate specimen for histological assessment may still be insufficient, especially when dealing with small lesions.

Publication History

Received: 01 November 2019

Accepted: 23 January 2020

Article published online:
23 March 2020

• References

• 1 Polkowski M, Jenssen C, Kaye P. et al. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline – March 2017. Endoscopy 2017; 49: 989-1006
• 2 Bang JY, Hebert-Magee S, Hasan MK. et al. Endoscopic ultrasonography-guided biopsy using a Franseen needle design: Initial assessment. Dig Endosc 2017; 29: 338-346
• 3 Mukai S, Itoi T, Katanuma A. et al. An animal experimental study to assess the core tissue acquisition ability of endoscopic ultrasound-guided histology needles. Endosc Ultrasound 2018; 7: 263-269
• 4 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
• 5 Abdelfatah MM, Grimm IS, Gangarosa LM. et al. Cohort study comparing the diagnostic yields of 2 different EUS-fine-needle biopsy needles. Gastrointest Endosc 2018; 87: 495-500
• 6 Mukai S, Itoi T, Yamaguchi H. et al. A retrospective histological comparison of EUS-guided fine-needle biopsy using a novel franseen needle and a conventional end-cut type needle. Endosc Ultrasound 2019; 8: 50-57
• 7 El Hajj II, Wu H, Reuss S. et al. Prospective assessment of the performance of a new fine needle biopsy device for EUS-guided sampling of solid lesions. Clin Endosc 2018; 51: 576-583
• 8 Haseeb A, Taylor LJ, Adler DG. Comparing endoscopic ultrasound-guided core biopsies of solid pancreatic and extrapancreatic lesions: a large single-operator experience with a new fine-needle biopsy needle. Ann Gastroenterol 2018; 31: 742-746
• 9 Leung KiEL, Lemaistre AI, Fumex F. et al. Macroscopic onsite evaluation using endoscopic ultrasound fine needle biopsy as an alternative to rapid onsite evaluation. Endosc Int Open 2019; 7: E189-E194
• 10 Ishikawa T, Kawashima H, Ohno E. et al. Clinical impact of EUS-guided fine needle biopsy using a novel Franseen needle for histological assessment of pancreatic diseases. Can J Gastroenterol Hepatol 2019; 2019: 8581743
• 11 Mohan BP, Shakhatreh M, Garg R. et al. Comparison of Franseen and fork-tip needles for EUS-guided fine-needle biopsy of solid mass lesions: A systematic review and meta-analysis. Endosc Ultrasound 2019; 8: 382-391
• 12 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
• 13 van Riet PA, Cahen DL, Biemann K. et al. Agreement on endoscopic ultrasonography-guided tissue specimens: Comparing a 20-G fine-needle biopsy to a 25-G fine-needle aspiration needle among academic and non-academic pathologists. Dig Endosc 2019; 31: 690-697
• 14 Sugiura R, Kuwatani M, Yane K. et al. Prospective, multicenter, observational study of tissue acquisition through EUS-guided fine-needle biopsy using a 25G Franseen needle. Endosc Ultrasound 2019; 8: 321-328
• 15 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
• 16 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
• 17 Uehara H, Sueyoshi H, Takada R. et al. Optimal number of needle passes in endoscopic ultrasound-guided fine needle aspiration for pancreatic lesions. Pancreatology 2015; 15: 392-396