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

Area of Science:

• Gastroenterology and Endoscopy
• Oncology
• Medical Devices

Background:

• Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) is crucial for histologic diagnosis and molecular profiling in precision medicine.
• Current manual biopsy needles face limitations in sample quality due to technique and needle manipulation.
• Optimizing tissue acquisition is essential for accurate tumor characterization.

Purpose of the Study:

• To compare a novel motorized EUS-FNB device (Precision) with a traditional manual device (SharkCore) for tissue acquisition in solid pancreas tumors.
• To evaluate differences in procedure time, number of throws, diagnostic yield, and histologic quality.
• To assess the potential of automated EUS-FNB for improving tumor sampling.

Main Methods:

• A pilot study involving patients with solid pancreas tumors.
• Each patient underwent tissue sampling using both the Precision motorized device and the SharkCore manual device.
• Key metrics included procedure time, number of passes and throws, diagnostic yield, and histologic scores.

Main Results:

• The motorized Precision device significantly reduced tissue sampling time (3.87 min vs. 5.64 min, P=.001) and the number of throws (5 vs. 55, P=.00002).
• Diagnostic yield was comparable between the two devices.
• The Precision device achieved a higher average histologic score (4.6/5) compared to SharkCore (3.2/5, P=.002).

Conclusions:

• Automated motorized EUS-FNB sampling may enhance histologic quality and consistency for tumor molecular profiling.
• The Precision device demonstrated potential for reduced procedure time and fewer needle manipulations.
• Larger studies are warranted to validate these findings for automated EUS-FNB in clinical practice.