New Biomarkers in the Intracystic Liquid of Cystic Pancreatic Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Role of the cyst fluid concentrations of the specific biomarkers for differentiation the pancreatic cystic lesions
研究概览
简要总结
Due to the advances made in the field of the imaging techniques and their common use, pancreatic cysts are more and more incidentally found.
Pancreatic pseudocysts can be misdiagnosed as cystic neoplasms, in particular when there is no clinical history of acute or chronic pancreatitis. Pancreatic cystic neoplasms on the other hand are rare, but are difficult to diagnose accurately.
Neutrophil gelatinase-associated lipocalin (NGAL) , interleukin 1 Beta (IL1beta) and High Mobility Group AT-Hook 2 (HmgA2) are molecules implicated in the process of inflammation and tumour development. The diagnostic value of their concentration in pancreatic cysts is not established yet.
Study aim to asses the significance of NGAL,IL1Beta and HMGA2 concentration in cystic fluid obtained by endoscopic ultrasound (EUS) with EUS-guided fine-needle aspiration (EUS-FNA) and serum level for discriminating between inflammatory and non-inflammatory pancreatic cyst.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18-90 years with an unclear specific diagnosis of pancreatic cysts
- •pancreatic cyst >15mm on CT or MRI
- •patients with pseudocysts with indication for drainage
排除标准
- •refusal to participate
- •platelet level < 50000/mm3 and International normalized ratio (INR >1.5)
- •duodenal stenosis
- •severe chronic pancreatitis
- •history of pancreatic cancer or major upper abdominal surgery
- •congestive heart failure
- •the liquid sample < 1ml;
结局指标
主要结局
Role of the cyst fluid concentrations of the specific biomarkers for differentiation the pancreatic cystic lesions
时间窗: through study completion, an average of 1 year
Measurement the cyst fluid concentration of NGAL, IL1beta, HMGA2, expressed in nanograms/dl
次要结局
- The Correlation between cyst fluid concentration and serum level of the specific biomarkers(through study completion, an average of 1 year)
研究者
Olar Miruna-Patricia
Principal Investigator
Iuliu Hatieganu University of Medicine and Pharmacy