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临床试验/NCT04389892
NCT04389892已完成不适用

Usefulness of Contrast-enhanced Harmonic Endoscopic Ultrasound (CH-EUS) for the Differentiation of the Pancreatic Cysts and for Guiding Endoscopic Ultrasound Guided Fine Needle Aspiration (EUS-FNA) From Murale Nodules.

Iuliu Hatieganu University of Medicine and Pharmacy2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
2
主要终点
Specific imaging characteristics using CH-EUS

研究概览

简要总结

The study evaluates the role of contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) for the differentiation of the pancreatic cysts and their malignant potential.

详细描述

Due to the increase use of cross-sectional imaging techniques for varied medical conditions more and more pancreatic cysts are incidentally found. Magnetic resonance imaging revealed a prevalence of incidental pancreatic cystic neoplasm (PCN) in adults between 2,4-49,1% and autopsy studies showed that half of the individuals had pancreatic cysts.

There is a great variety of pancreatic cysts, they are mainly divided in neoplastic or non-neoplastic (i.e pseudocyst). Pseudocysts appear after acute or chronic pancreatitis and represent only 20% of all pancreatic cysts.. PCN include a diverse group of pancreatic cysts including mucin-producing (Intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN)) and nonmucin-producing lesions (Serous cystadenoma (SCN), Solid pseudopapillary neoplasm(SPN) cystic neuroendocrine tumor(cNET)) with different morphology and progression to malignancy. SPN's,cNET are considered premalignant or malignant conditions and require surveillance or surgical resection. SCN instead are benign and surveillance is not necessary. Resection is considered only if symptoms are present.

The discrimination between the different cyst types is crucial for the therapeutic approach. Their morphology can be similar and sometimes it's a challenge to diagnose them.There are many tools but none is good enough to be used alone.

Contrast-enhanced harmonic endoscopic ultrasound using low mechanical index (0.12-0.4) is an additional test to assess the vascularization of the cystic wall and the septa and solid component for the differential diagnosis of PCN.

Our aim was to identify specific imaging characteristics using CH-EUS in order to increase the diagnostic accuracy for potential malignant pancreatic cysts.

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

入选标准

  • presence of an undetermined pancreatic cyst >10mm (Computer tomography, Magnetic resonance imaging);
  • written informed consent.

排除标准

  • platelet count under 50.000 platelets per microliter (mcL)
  • patients with cardiorespiratory instability
  • refuse of the patient to participate.

结局指标

主要结局

Specific imaging characteristics using CH-EUS

时间窗: Baseline

To identify specific imaging characteristics using CH-EUS ( the contrast uptake pattern) in order to increase the diagnostic accuracy for the different type of the pancreatic cysts

Differentiation between murale nodules and mucus clots or debris

时间窗: Baseline

The role of CH-EUS for the identification of true mural nodules

次要结局

  • Guiding EUS-FNA by the enhancement pattern(One month)

研究者

发起方
Iuliu Hatieganu University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olar Miruna-Patricia

Principal Investigator

Iuliu Hatieganu University of Medicine and Pharmacy

研究点 (2)

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