Prospective Evaluation of the Significance of the Pro-core® Needle in Differential Diagnosis of Tumorous and Inflammatory Processes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Diagnostic Accuracy
研究概览
简要总结
The study is designed to evaluate the diagnostic accuracy of a new designed endoscopic ultrasonography (EUS) Core biopsy aspiration needle in comparison to a conventional EUS aspiration needle in GI-tumors.
详细描述
Endoscopic ultrasound is an established examination method for tumors of the gastrointestinal tract and the pancreas. Since imaging by itself is limited in differential diagnosis of tumors, EUS guided fine needle aspiration is seen as a valid complementary method. Since fine-needle aspiration (FNA) is mainly based on cytological diagnostics, this method is limited also because of lacking supplementary immune- histochemical diagnostics. Here, the obtainment of little histologically evaluable tissue samples (punched barrels) would be of benefit.
A new punch needle device called Pro-core needle (Cook)(22 / 19 gauges) offers the possibility of increasing numbers of valid extractions of histologically evaluable tissues due to a better targeted precision and maneuverability in comparison to other devices of that kind (tru-cut needles, e.g.). A little notch at the pinpoint allows the obtainment of little tissue samples, that will be kept within the device by aspiration.
This study compares the obtainment of tissue by Proc-core needle and conventional aspiration punction systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical indication for endoscopic ultrasound diagnostics with fine needle biopsies
- •age greater than 18 years
排除标准
- •difficult or impossible approach to desired structures due to anatomy (postoperative anatomy, e.g.)
- •cystic lesion, e.g. cystic pancreas tumors
- •coagulopathy
- •severe general condition of the patient
- •other contraindications for endoscopical ultrasound aided fine needle punction
结局指标
主要结局
Diagnostic Accuracy
时间窗: up to 1 year
Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts. The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard.
次要结局
- Complication Rates(day 0 and day 14)
- EUS Pro Core FNA: Histology Samples(day 0 and day 14)
研究者
Prof. Dr. Thomas Rösch
Medical Director, Interdisciplinary Endoscopy Department and Clinic
Universitätsklinikum Hamburg-Eppendorf