Motorized Fine Needle Biopsy vs Standard Needles

Instituto Ecuatoriano de Enfermedades Digestivas

Status

Enrolling

Conditions

Pancreas Disease

Liver Diseases

Treatments

Device: EUS-guided motorized fine needle biopsy

Device: EUS-guided standard fine needle biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT06298604

IECED-12112023

Details and patient eligibility

About

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.

Full description

The development of Endoscopic ultrasound-guided tissue acquisition (EUS-TA) has been remarkable. Initially focused on obtaining samples from the pancreas, it has expanded significantly to include various organs adjacent to the gastrointestinal system (i.e., liver, lymph nodes, adrenal glands).

One of the key advancements in EUS-TA involves the shift from cytological analysis, with fine-needle aspiration (FNA), to histological and even genetic evaluations, with fine-needle biopsies (FNB). FNB addresses some limitations associated with FNA, such as low tumor cellularity and the inability to retain cellular architecture.

Recent improvements in puncture techniques and needles, allow for the collection of high-quality specimens, comparable to core needle biopsy, to achieve standards for specimen adequacy (i.e., intact liver cores of at least 15-20 mm with a complete portal triad count of 11). Some current available needle designs include the crown type, flanged type, 20 Gauge FNB needles with forward-faced core traps, and the fork-tip needles, demonstrating high diagnostic accuracy and a low rate of adverse events.

The Precision-GI is a new motorized fine needle (mFNB) developed by LIMACA Medical in Israel for EUS-guided FNB. It operates using a battery-powered motor that enables controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition. Moreover, a sharp stylet facilitates crossing through the gastrointestinal wall, allowing for the reach of target lesions. The rotational electromechanical cutting movement into the lesion promises intact motorized tissue acquisition without sample damage.

In the present study, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of EUS-guided pancreatic and liver specimens. 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.