Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of the Micro-Tech FNB needle in obtaining pancreatic malignancy
研究概览
简要总结
Systemic chemotherapy can improve disease-related symptoms and/or prolong survival in patients with pancreatic cancer. Before the start of chemotherapy, the diagnosis pancreatic carcinoma must be confirmed by tumor tissue samples, which are often obtained during endoscopic ultrasound (EUS) by fine needle aspiration (FNA) or fine needle biopsy (FNB). Obtaining core biopsies by FNB has several potential benefits, such as making a more reliable diagnosis, performing immunohistochemistry for diagnostic reasons and in the future obtaining enough malignant cells to deliver personalized based chemotherapy regimen based on mutations detected by next generation sequencing. Obtaining high quality and sufficient tumor material is essential for genomic profiling with a preference of FNB over FNA. Up to now, no specific FNB needle has been found to be superior in diagnostic accuracy and in obtaining tissue for genomic profiling. In this study, we aim to evaluate the diagnostic accuracy of a new FNB needle (Micro-Tech Europe GmbH, Düsseldorf, Germany) and we study the adequacy of the obtained tissue samples for performing genetic sequencing.
详细描述
This study is an international multicenter prospective cohort study. The study will be performed in collaboration with the disciplines of Gastroenterology and Pathology of the participating hospitals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Clinical suspicion of pancreatic adenocarcinoma
- •Indication for obtaining EUS-guided histology of a suspected pancreatic lesion
- •Written informed consent
排除标准
- •Contra-indications to undergoing an EUS (e.g., oropharyngeal abnormalities)
- •Altered anatomy (e.g., after previous Whipple-operation, Roux-and-Y gastrojejunostomy)
- •Contra-indications to the administration of benzodiazepines, propophol or opioids
- •Pregnancy
- •Insufficient knowledge of the Dutch language to be able to understand the patient information
结局指标
主要结局
Diagnostic accuracy of the Micro-Tech FNB needle in obtaining pancreatic malignancy
时间窗: 2 years
Pathologist scores the obtained specimen according the Bethesda system. Diagnostic accuracy will be quantified by the sensitivity and specificity and expressed as frequency of pancreatic malignancy as confirmed by histological evaluation.
次要结局
- Ability to perform genetic sequencing on the sample(2 years)
- Puncture success rate(2 years)
- User experience(2 years)