Comparison Between a Novel Motorized EUS Guided Fine Needle Biopsy (FNB) With Standard Needle for Pancreatic and Liver Biopsies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy according to histological analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
Single masking, the pathologist will be blinded to the needle used for sample collection.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Standard EUS-guided FNB
Patients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a standard 19-gauge needle
干预措施: EUS-guided standard fine needle biopsy (Device)
Motorized EUS-guided FNB
Patients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a motorized 20-gauge needle.
干预措施: EUS-guided motorized fine needle biopsy (Device)
结局指标
主要结局
Diagnostic accuracy according to histological analysis
时间窗: Up to one week
Proportion of subjects with a definitive diagnosis based on the number of passes and throws for tissue acquisition.
Endoscopic ultrasound fine needle biopsy sample quality
时间窗: Up to two hours after the procedures
Based on tissue "core"; Tissue core is defined as a architecturally intact piece of at least 550 micron in the greatest axis. The tissue core will be evaluated in both groups by the pathologist immediately after its acquisition.
次要结局
- Tissue blood contamination(Up to one hour)
研究者
Carlos Robles-Medranda
Head of the Endoscopy Division
Instituto Ecuatoriano de Enfermedades Digestivas