Randomized Trial Comparing the Franseen Needle Versus Two Types of Sharpened-Tip Three-Prong Needles in Endoscopic Ultrasound-Guided Tissue Acquisition from Solid Pancreatic Lesions.

Abstract

Background and aims: Endoscopic ultrasound-guided tissue acquisition (EUS-TA) is crucial for diagnosing pancreatic diseases. Recently, two novel types of sharpened-tip, three-prong fine-needle biopsy (FNB) needles, the Trident needle and the 3-point needle, have been 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, with secondary endpoints including histological diagnosis, tissue volume, initial puncture success, puncture performance, and adverse events.

Results: In total, 185 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% confidence interval: -9.53-1.12), 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 histological 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 histological diagnostic performance or the 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.