跳至主要内容
临床试验/NCT03738280
NCT03738280已完成不适用

Role of EUS in Differential Diagnosis and Malignancy Prediction of Non-hypovascular Solid Pancreatic Lesions: A Prospective Observational Study

Azienda Ospedaliera Universitaria Integrata Verona1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
1
主要终点
Upstream dilation of the main pancreatic duct

研究概览

简要总结

Vascular pattern of solid pancreatic lesions (SPLs) has been investigated by different abdominal imaging modalities and by contrast-enhanced endoscopic ultrasonography (CE-EUS). Compared with surrounding pancreatic parenchyma three different patterns have been described: hypo-, iso-, and hypervascular. The majority of SPLs are hypovascular, and the diagnostic relevance of hypoenhanced pattern to predict pancreatic adenocarcinoma (PDAC) is well established. Differently, iso- and hypervascular pattern is not specific and can be expressed by several SPLs, with different clinical behavior and management. To date, poor is know about the role of EUS in differential diagnosis of non-hypovascular SPLs and features associated with malignancy.

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

入选标准

  • Presence of one or more solid pancreatic lesions preliminary evaluated by contrast-enhanced computed tomography (CE-CT) and/or contrast enhanced magnetic resonance imaging (CE-MRI) reporting a non-hypovascular contrast pattern (e.g., iso- or hypervascular).

排除标准

  • Patients with associated chronic pancreatitis features (e.g., pancreatic calcifications)
  • Lesion with hypovascular pattern at CE-EUS.
  • Lesion not found or non pancreatic at EUS.
  • Patients refusing to be included in the study

结局指标

主要结局

Upstream dilation of the main pancreatic duct

时间窗: 6 months

Percentage of cases with upstream dilation of main pancreatic duct will be recorded.

Lesion borders (smooth or irregular)

时间窗: 6 months

Percentage of cases with smooth or irregular borders will be recorded.

Vascular pattern (iso or hypervascular)

时间窗: 6 months

Percentage of cases with iso-vascular or hyper-vascular pattern will be recorded.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Francesco Crinò, MD

Principal Investigator

Azienda Ospedaliera Universitaria Integrata Verona

研究点 (1)

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