Evaluation of a Novel Motorized EUS-Guided Fine-needle Biopsy Device and Pathology Quality Parameters Comparison to Standard Fine-needle Biopsy: A Prospective Pilot Study

Aims The actual efficacy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) in practice depends on the site, size, characteristics of the target tissue, as well as the availability of a cytopathologist to render an on-site diagnosis [1] [2]. Fine-needles designed to obtain biopsy (FNB) specimens allow core samples to be collected by shearing tissue from the target lesion. This is a novel motorized EUS-FNB (mFNB) which enables increased yield, bigger sample size retrieval with improved quality and fewer needle passes, providing tissue with conserved architecture and less blood contamination, enabling a better histological analysis. We aim to evaluate the safety, efficacy and comfortability of the mFNB and compare its performance to a standard FNB (sFNB).

Methods A single-center, prospective, pilot study performed in patients that required EUS-guided biopsy from September 2023 to November 2024. Patients scheduled for EUS-FNB, including patients with submucosal lesions, mediastinal masses, lymphatic nodes, pancreatic cancer and intraperitoneal masses, who were at least 18 years old.

Results Forty participants were included in the study, mean age was 65,0 (57.8 – 69.2) and 57.5% were female. Most biopsies were liver biopsies (55%), mean number of stabs was 4 (± 2). A mild adverse event (mucosal laceration) was reported with mFNB (2.5%). The mFNB obtained a 97.5% technical success. Biopsy was definitive in 95.0% with two cases reporting inadequate samples. When comparing mFNB vs sFNB performance: mFNB blood contamination was reported as lower than 25% in 90% of cases, while 72.5% of sFNB samples reported moderate contamination (50% of blood contamination in histological slides). Both FNBs obtained architecturally intact tissue samples in 95% of cases; however, 87.5% of mFNB had a piece of at least 550μm, while sFNB 2.5%. 65% of mFNB samples were multiple fragments with at least one>5mm in length (42.3% at least one fragment>10mm); 52.5% of sFNB samples were>5mm in length (2.5% had one fragment>10mm). A median number of portal triads observed 6 (4-8) with mFNB, and 2 (0.5-2.75) with sFNB. Comfortability of the mFNB was evaluated using a 5-Point Likert Scale, considering the following: determining a preferred sheath length by adjusting the sliding sheath adjuster, comfortable to adjust the stopper lock position, comfortable to advance the needle into the lesion, comfortable to withdraw the stylet, comfortable to sample tissue by pushing the sampling button, comfortable to expel the biopsy sample. All parameters obtained a high agreement (> 95%).

Conclusions mFNB is safe and efficient to perform during EUS-FNB, with low adverse event rates and high technical success. Operators indicated high clinical expectations and comfortability regarding the different components of the needle. mFNB obtained larger tissue samples with less blood contamination compared to sFNB.

 

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Conflicts of Interest

Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. All other authors have nothing to declare.

• References

• 1 Itoi T, Sofuni A, Itokawa F.. et al. Current status of diagnostic endoscopic ultrasonography in the evaluation of pancreatic mass lesions. Dig Endosc 2011; 23 (01): 17-21
• 2 Rodrigues-Pinto E, Grimm IS, Baron TH.. Endoscopic ultrasound fine-needle aspiration vs. fine-needle biopsy: tissue is always the issue. Endosc Int Open 2016; 4 (05): E506-E507

Publication History

Article published online:
27 March 2025