Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore): A Prospective Randomized, Controlled Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method
研究概览
简要总结
Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.
详细描述
Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for the diagnosis and evaluation of lesions of the pancreas, the upper gastrointestinal tract, as well as adjacent structures, including lymph nodes. Cytology specimens provided from FNA cannot fully characterize certain neoplasms such as lymphomas or mesenchymal tumors. Core biopsy specimens for histological examinations are needed to provide accurate diagnoses.
ProCore needles (ProCore, Wilson-Cook Medical Inc. Winston-Salem, NC) were designed to obtain histological and cytological samples. Studies comparing ProCore needles with standard FNA needles showed no significant difference in diagnostic accuracy, histological core tissue procurement or mean number of passes.
To overcome the above mentioned limitations (mainly suboptimal core tissue procurement rates), a new novel SharkCore needle (Beacon Endoscopic, Newton, MA, USA) has been designed and approved for clinical human use by the FDA.
The objective of the study is to compare the new EUS guided histology biopsy needle SharkCore to the currently used EUS histology needle, ProCore, for the histological diagnosis and evaluation of lesions.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age referred for EUS
- •Lesions requiring histologic diagnosis:
- •Mesenchymal tumors
- •Autoimmune pancreatitis
- •Granulomatous disease
- •Indeterminate hepatitis
- •Confirmatory immunochemistry to establish a diagnosis (i.e. pancreatic neuroendocrine tumor)
- •Solid tumors
- •Previously non-diagnostic FNA
排除标准
- •Uncorrectable coagulopathy (INR > 1.5)
- •Uncorrectable thrombocytopenia (platelet < 50,000)
- •Uncooperative patients
- •Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- •Refusal to consent form
- •Cystic lesions
- •Inaccessible lesions to EUS (proximal to sigmoid colon or distal to second duodenum)
结局指标
主要结局
Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method
时间窗: Up to 1 month
The final diagnosis of tissue from needle will be compared to the final diagnosis reached either by surgical removal of mass or other method of biopsy
次要结局
- Number of passes to procure core tissue from needle(During procedure)
- Safety of tissue procurement by needle(Up to 1 year)
- Procedure time(During procedure)
研究者
Mouen Khashab
Associate professor
Johns Hopkins University