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.

Randomized trial comparing the 25G and 22G Franseen needles in endoscopic ultrasound‐guided tissue acquisition from solid pancreatic masses for adequate histological assessment

“…Therefore, if the diagnostic yields among different‐sized needles are equal, a thinner needle would be preferable. Two previous studies reported the outcome of EUS‐FNB with the 25G Franseen needle, reporting adequate tissue acquisition rates of 79.3% and 95.0%, respectively 17,18 . In this study, the 25G Franseen needle was comparable to the 22G needle in terms of procurement of adequate tissue samples from pancreatic masses.…”

“…Two previous studies reported the outcome of EUS-FNB with the 25G Franseen needle, reporting adequate tissue acquisition rates of 79.3% and 95.0%, respectively. 17,18 In this study, the 25G Franseen needle was comparable to the 22G needle in terms of procurement of adequate tissue samples from pancreatic masses. Moreover, sampling with the 25G needle provided equivalent diagnostic accuracy to the 22G needle, although EUS-FNB was technically easier with 25G than with 22G.…”

Comparison between Two Types of 22-Gauge Fine-Needle Biopsy for Solid Pancreatic Tumors

“…The differences between the 22- and 25-gauge FNB needles have not been extensively studied. Two studies detailed the performance of 25-gauge FNB Franseen needles, reporting sample adequacy rates of 79 and 82%, respectively, which may be inferior to the aforementioned rates for 22-gauge needles [ 22 , 23 ]. A randomized prospective study compared diagnostic yields for 25- and 22-gauge Franseen needles in patients with solid pancreatic lesions finding no significant difference in diagnostic yield (98 vs. 88%, p = 0.105, respectively), however finding that the 25-gauge group required additional passes to obtain an adequate cell block (1.6 ± 0.6 vs. 0.4 ± 0.7, p = 0.001) [ 24 ].…”

Endoscopic ultrasonography‐guided tissue acquisition for small solid pancreatic lesions: Does the size matter?

“…In a recent meta-analysis of seven randomized controlled trials (RCTs), 44 a 25-gauge FNA needle is not superior to a 22-gauge FNA needle in sensitivity and adequacy for the diagnosis of SPLs. As described above, estimated pooled ORs in our meta-analysis suggested the lower sensitivity in small SPLs was less prominent when a 25-gauge needle was used (Figure 5a), as compared to studies without the use of a 25gauge needle.However,there has been no head-to-head comparative study of 25-and 22-gauge needles in small SPLs.Furthermore,effectiveness of 25-gauge FNB needles has been reported in SPLs, [45][46][47] though one study did suggest sensitivity and adequacy decreased in small SPLs even using a 25-gauge FNB needle. 47 A prospective comparative study is warranted to elucidate whether a 25-gaguge FNA or FNB needle would provide better diagnostic yield in small SPLs or not.…”

“…However, there has been no head‐to‐head comparative study of 25‐ and 22‐gauge needles in small SPLs. Furthermore, effectiveness of 25‐gauge FNB needles has been reported in SPLs, 45 , 46 , 47 though one study did suggest sensitivity and adequacy decreased in small SPLs even using a 25‐gauge FNB needle. 47 A prospective comparative study is warranted to elucidate whether a 25‐gaguge FNA or FNB needle would provide better diagnostic yield in small SPLs or not.…”