Motorized endoscopic ultrasound biopsy needle compared to traditional sampling technique

Introduction: Obtaining core biopsies using endoscopic ultrasound-guided fine-needle biopsy (EUSFNB) needles for histological diagnosis and tumor molecular profiling is needed in the era of precision medicine. However, sample quality is impacted by several factors; needle type, number of passes and technique. Currently, all available biopsy needles are manually operated. A new motorized endoscopic ultrasound electro-mechanical revolving needle has been developed to standardize and improve tissue acquisition. This unique cutting needle design along with the rotation-axial motion produces smooth tissue cutting and intact core-tissue quality, without crushing the samples. The combination of the axial and the rotational movements enables efficient and smooth tissue cutting, producing better core-tissue quality and volume. The study is the first to compare a motorized approach to traditional manual technique. Methods: Patients with solid pancreas tumors or lymphadenopathy were eligible for enrollment. Each patient had the lesion sampled by both motorized needle (19g) and manual needle (Sharkcore), 22g, biopsy method. The study was approved by the IRB. Procedure measures included; number of passes, diagnostic yield, and histologic scores. Microscopic grading scale of the histological quality of the specimen from 1 to 5 scale (1 =poor, non-diagnostic yield) to 5 (excellent, completely diagnostic yield). Results: Ten patients were enrolled, 7males and 3 females, with an average age of 71 years old. There were 9 pancreas tumors with an average size of 30 mm and one lymph node (30mm). The average number of passes was 1 in motorized group compared to 1.5 in manual group. The diagnostic yield was similar in both arms. However, histologic scores and ability for molecular profiling was higher in the automated group at 100% and 96% compared to 73% and 60% in the manual group (Figure 1). Conclusion: FNB is the method of choice for tumor acquisition. The initial results of this study suggest an automated motorized needle biopsy approach may lead to more consistent histologic quality along with the ability for molecular profiling of tumors with fewer passes. Future larger studies are need to validate these findings. This is the first human feasibility trial using a motorized needle during endoscopic ultrasound.