Randomized trial comparing the Franseen needle versus 2 types of sharpened-tip 3-prong needles in EUS-guided tissue acquisition from solid pancreatic lesions - 15/10/25
, Hirotaka Suzuki, MD, PhD 2, Yasuki Hori, MD, PhD 3, Jun Yashika, MD, PhD 4, Hiroki Suhara, MD, PhD 5, Hajime Sumi, MD, PhD 6, Masahiko Ando, MD, PhD 7, Yachiyo Kuwatsuka, MD, PhD 7, Kentaro Yamao, MD, PhD 1, Yasuyuki Mizutani, MD, PhD 1, Tadashi Iida, MD, PhD 8, Kota Uetsuki, MD, PhD 1, Takeshi Yamamura, MD, PhD 1, Kazuhiro Furukawa, MD, PhD 1, Masanao Nakamura, MD, PhD 8, Hiromi Kataoka, MD, PhD 3, Hiroki Kawashima, MD, PhD 1Abstract |
Background and Aims |
EUS-guided tissue acquisition (EUS-TA) is crucial for diagnosing pancreatic diseases. Recently, 2 novel types of sharpened-tip, 3-prong fine-needle biopsy (FNB) needles, the Trident needle (Micro-Tech Endoscopy, High Wycombe, UK) and the 3-point needle (TopGain; MediGlobe, London, UK), were developed to improve puncture performance. In this study, these novel needles were compared with the conventional Franseen needle in EUS-TA from solid pancreatic lesions (SPLs).
Methods |
In this prospective, multicenter, randomized controlled trial, patients with SPLs ≥10 mm were randomized for use of either conventional or novel FNB needles. The primary endpoint was the tissue collection rate, and secondary endpoints were histologic diagnosis, tissue volume, initial puncture success, puncture performance, and adverse events.
Results |
One hundred eighty-five patients were analyzed. The tissue collection rates were 96.8% for the conventional needle and 92.6% for the novel FNB needles. The novel needles presented slightly lower tissue collection rates, although this difference was not statistically significant. Furthermore, this difference was –4.2% (90% CI, –9.53 to 1.12), which did not indicate noninferiority. However, the novel needles significantly outperformed the conventional needles in terms of initial puncture success and overall puncture performance. No significant differences were found in histologic diagnosis, tissue volume, or adverse events between the groups.
Conclusions |
The conventional FNB needle demonstrated a higher tissue collection rate but did not surpass the noninferiority margin that was set in this study, with no significant differences in the histologic diagnostic performance or tissue volume between the needles. The superior puncture performance of the novel needles suggests their particular benefit in challenging cases or for less-experienced endoscopists. (Clinical trial registration number: jRCT1042220099.)
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Abbreviations : AE, CGP, EUS-TA, FNB, NOP, OR, SPL
Plan
| DIVERSITY, EQUITY, AND INCLUSION: We worked to ensure gender balance in the recruitment of human subjects. We worked to ensure ethnic or other types of diversity in the recruitment of human subjects. We worked to ensure that the language of the study questionnaires reflected inclusion. The author list of this paper includes contributors from the location where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work. |
Vol 102 - N° 5
P. 703-713 - novembre 2025 Retour au numéro
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