Endoscopic Ultrasound-Guided Fine Needle Biopsy Using 22-Gauge Franseen Needle for the Histological Diagnosis of Solid Lesions: A Multicenter Prospective Pilot Study

Mita, Naoki; Iwashita, Takuji; Uemura, Shiro; Iwasa, Yuhei; Toda, Katsuhisa; Mukai, Tsuyoshi; Miyazaki, Tatsuhiko; Yasuda, Ichiro; Shimizu, Masahito

doi:10.1007/s10620-019-05840-y

Cited by 26 publications

(34 citation statements)

References 31 publications

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“…Among prospective studies evaluating the Franseen needle alone[ 22 , 23 ], prospective comparative studies evaluating the Franseen needle vs FNA[ 5 , 27 , 28 ] and a prospective comparative study evaluating the Franseen needle vs Fork-tip needle[ 12 ], three studies[ 5 , 12 , 27 ] included only pancreatic lesions. In the other three studies[ 22 , 23 , 28 ] pancreatic lesions represented between 52% and 81% of the targeted lesions. Sugiura et al[ 23 ] prospectively assessed the 25G Franseen needle, whereas all other trials assessed the 22G Franseen needle.…”

Section: Discussionmentioning

confidence: 99%

“…Like our standardised protocol of only two passes, a predetermined number of passes was performed by the following trials. Mita et al[ 22 ] performed three passes, reporting an acquisition rate of adequate specimen for histological assessment (cellularity score ≥ 4) of 90.7% on the first pass and 98.7% on the best of three passes. Sugiura et al[ 23 ] performed one pass with the 25G Franseen needle, resulting in an acquisition rate of adequate specimen for histological assessment (cellularity score ≥ 4) of 81.5% when targeting pancreatic lesions.…”

Section: Discussionmentioning

confidence: 99%

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Endoscopic ultrasound-fine needle biopsies of pancreatic lesions: Prospective study of histology quality using Franseen needle

Stathopoulos¹,

Pehl²,

Breitling³

et al. 2020

WJG

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BACKGROUND The introduction of fine needle biopsies (FNB) to clinical practice presents a changing trend towards histology in the endoscopic ultrasound-guided tissue acquisition (EUS-TA). AIM To evaluate the clinical performance of a new FNB needle, the 22-gauge (22G) Franseen needle, when sampling pancreatic solid lesions. METHODS Consecutive patients with an indication for EUS-TA for the assessment of pancreatic solid lesions were included in this prospective, single-center, single-arm trial. Each patient underwent a puncture of the lesion two times using the 22G Franseen needle and the obtained samples were directly placed into formalin for histological analysis. The primary study endpoint was the rate of high-quality obtained specimen. Secondary endpoints included the length and diameter of the core specimen, the diagnostic accuracy and the complication rate. RESULTS From June 2017 to December 2018, forty patients with pancreatic solid lesions (22 females; mean age 67.2 years) were enrolled. Tissue acquisition was achieved in all cases. High-quality histology, rated with Payne score 3, was obtained in 37/40 cases (92.5%) after two needle passes. The mean size of the acquired histological core tissue was 1.54 mm × 0.39 mm. The diagnostic accuracy for the correct diagnosis was 85% (34/40). Only one adverse event was occurred, consisting of a self-limiting bleeding in the puncture site. CONCLUSION The 22G Franseen needle achieved according to our standardized protocol a high rate of histological core procurement, and a high diagnostic accuracy, with one minor adverse event reported.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Endoscopic ultrasound-fine needle biopsies of pancreatic lesions: Prospective study of histology quality using Franseen needle

Stathopoulos¹,

Pehl²,

Breitling³

et al. 2020

WJG

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“…We also assessed the diagnostic accuracy of the AC22 in this study. The AC22 is a relatively new needle with a diagnostic accuracy of 94.0 to 96.7% [30][31][32]. Iwashita et al [33] reported that the AC22 was better than a conventional needle in acquiring cells.…”

Section: Discussionmentioning

confidence: 99%

“…The AC22 is designed to hold and cut the tissue with multiple sharp structures on the tip (fork tip). This characteristic structure contributes to better sample collection even in a lesion with dense brotic change, different from most conventional EUS-FNA needles [31,34]. In an animal experiment, there was no signi cant difference in the core tissue acquisition ability between the PC20 and AC22 [21].…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of introducing a 20-gauge core biopsy needle with a core trap in EUS-FNA/B for diagnosing pancreatic cancer

Watanabe

Miyoshi

Toki

et al. 2020

Preprint

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Background: Endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) is a standard method for pathological diagnosis of pancreatic solid lesions. The EchoTip ProCore 20G® (PC20), a 20-gauge biopsy needle with a forward-bevel core trap, has been available in Japan since 2015.Methods: We compared the efficacy of the PC20 with that of the EchoTip ProCore 22G® (PC22) and Acquire 22G® (AC22) in EUS-FNA/B for diagnosing pancreatic cancer. This retrospective study included 191 patients with pancreatic cancer who underwent EUS-FNA/B using the PC20, PC22, or AC22 at our facility from April 2013 to October 2019. We investigated the patients’ clinical characteristics and the diagnostic accuracy and safety of each needle.Results: A sufficient stroke length of puncture was secured in all patients. The maximum length under EUS was shorter with the AC22 (22.1±2.2 mm) than PC20 (30.6±0.7 mm, p<0.01) and PC22 (30.3±0.8 mm, p<0.01). The histological accuracy was 96.4% with the PC20 but only 58.8% with the PC22 (adjusted p (p-adj)<0.0001) and 75.0% with the AC22 (p-adj=0.06). The diagnostic accuracy of the combination of histology and cytology was 96.4% with the PC20, while it was 72.1% with the PC22 (p-adj<0.0001) and 91.7% with the AC22 (p-adj>0.99). One patient (0.9%) in the PC20 group developed mild pancreatitis, but no adverse events occurred with the other needles. Conclusions: The PC20 showed better diagnostic capability than the PC22. The diagnostic efficacy was similar between the PC20 and AC22. The high histological accuracy of the PC20 could be advantageous for lesions in which histological assessment is critical.

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“…The Franseen biopsy needle, a fine-needle biopsy (FNB) needle developed to collect multiple tissue samples for obtaining a histological diagnosis, has attracted substantial attention recently owing to its advanced diagnostic capabilities and superiority relative to conventional fine-needle aspiration (FNA) needles. [ 10 11 12 13 14 15 16 17 ] Advanced diagnostic capabilities of new-generation biopsy needles may even eliminate the need for ROSE. [ 18 ]…”

Section: Introductionmentioning

confidence: 99%

Diagnostic efficacy of white core cutoff lengths obtained by EUS-guided fine-needle biopsy using a novel 22G franseen biopsy needle and sample isolation processing by stereomicroscopy for subepithelial lesions

et al. 2020

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Endoscopic Ultrasound-Guided Fine Needle Biopsy Using 22-Gauge Franseen Needle for the Histological Diagnosis of Solid Lesions: A Multicenter Prospective Pilot Study

Cited by 26 publications

References 31 publications

Endoscopic ultrasound-fine needle biopsies of pancreatic lesions: Prospective study of histology quality using Franseen needle

Endoscopic ultrasound-fine needle biopsies of pancreatic lesions: Prospective study of histology quality using Franseen needle

Effectiveness of introducing a 20-gauge core biopsy needle with a core trap in EUS-FNA/B for diagnosing pancreatic cancer

Diagnostic efficacy of white core cutoff lengths obtained by EUS-guided fine-needle biopsy using a novel 22G franseen biopsy needle and sample isolation processing by stereomicroscopy for subepithelial lesions

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