Gastrointestinal endoscopy · 2025
Randomized trial comparing the Franseen needle versus 2 types of sharpened-tip 3-prong needles in EUS-guided tissue acquisition from solid pancreatic lesions.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Ishikawa Takuya, Suzuki Hirotaka, Hori Yasuki, Yashika Jun, Suhara Hiroki, Sumi Hajime, Ando Masahiko, Kuwatsuka Yachiyo, Yamao Kentaro, Mizutani Yasuyuki, Iida Tadashi, Uetsuki Kota, Yamamura Takeshi, Furukawa Kazuhiro, Nakamura Masanao, Kataoka Hiromi, Kawashima Hiroki
Аннотация
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.).
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.).