Motorized Fine Needle Biopsy vs Standard Needles
NCT06298604
Summary
Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition. Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.
Eligibility
Inclusion Criteria: * Patients between 18 and 99 years * Patients referred to our center who require EUS-guided liver or pancreas biopsy. * Male or female patients. * Patients able to give consent Exclusion Criteria: * Pregnancy or nursing * Patients with coagulation disorders (platelets \<50.000/mm3, international normalised ratio (INR) \>2) * Any underlying medical condition that contraindicates EUS-guided fine needle biopsy such as anatomical alterations, significant gastric outlet obstruction, collateral intervening vessels.
Conditions3
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NCT06298604