Pilot study comparing a novel EUS-guided motorized biopsy needle technique with traditional sampling

Improving tissue acquisition in core samples using EUS-guided fine-needle biopsy sampling (EUS-FNB) for histologic diagnosis and tumor molecular profiling is needed for the era of precision medicine. However, sample quality is impacted by needle type, number of throws, and technique. Currently, all commercially available biopsy needles are manually operated. This pilot study is the first to compare Precision (Limaca Medical, Ein HaEmek, Israel), a new motorized EUS-FNB device programmed to drive controlled axial tissue cutting and synchronized high-speed rotational coring to optimize tissue acquisition and physician control, with SharkCore (Medtronic Corp., Minneapolis, MN) using a traditional manual technique.

Patients with solid pancreas tumors were eligible for enrollment. Each patient's target lesion was sampled by both Precision and SharkCore. Procedure measures were number of passes and throws, diagnostic yield, and histologic scores.

Nine patients were enrolled. The average tissue sampling time using Precision was 3.87 minutes compared with 5.64 minutes with SharkCore (P = .001). Average Precision throws were 5 compared with 55 for SharkCore (P = .00002). The diagnostic yield was similar in both arms. However, the average histologic score of Precision was higher (4.6/5) compared with SharkCore (3.2/5, P = .002).

EUS-FNB is the method of choice for tumor data acquisition. The initial results of this pilot study suggest an automated motorized needle biopsy sampling approach may lead to more consistent histologic quality along with the ability for molecular profiling of tumors with fewer throws and passes reducing average procedure time. Future larger studies are needed to validate these findings.