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临床试验/NCT02692430
NCT02692430Unknown不适用

LARGE SPONTANEOUS PORTOSYSTEMIC SHUNTS (SPSSs) IN PATIENTS WITH LIVER CIRRHOSIS. CLINICAL AND RADIOLOGICAL CHARACTERISTICS.

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Number of cirrhotic patients that develop hepatic encephalopathy as a decompensation

研究概览

简要总结

The purpose of this study is to perform a multicentre registry of cirrhotic patients who had been submitted to an imagining technique in recent years (angio-CT scan or abdominal MRI), in order to collect anatomical and clinical information. The main objective will be focused on the study of portosystemic shunts and their relation with portal hypertension.

Patient with liver cirrhosis submitted to an abdominal angio-CT scan or a MRI from year 2010 to 2014 will be included in the study. The chosen imaging technique will be angio-CT preferably, but MRI data will also be available. Patients will be identified in every hospital by means of the registry of coded diagnoses and the lists of complementary tests performed. Clinical and radiological data of every patient will be collected. The clinical variables will be obtained from reviewing the patient clinical history. The radiological parameters will be gathered by means of the systematic review of the angio-CT or MRI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Liver cirrhosis
  • An evaluable imaging test (angio-CT or MRI) performed by any reason in the study period (from January 2010 to December 2014)

排除标准

  • Presence of previous surgical shunts
  • Prior liver transplant
  • Neurological or psychiatric disorder that do not permit to establish the diagnosis of hepatic encephalopathy
  • Presence of hepatocellular carcinoma beyond Milan criteria
  • Terminal disease

结局指标

主要结局

Number of cirrhotic patients that develop hepatic encephalopathy as a decompensation

时间窗: 4 years

Number of cirrhotic patients with a portosystemic shunt detected by angio-CT scan or MRI

时间窗: 4 years

次要结局

  • Number of cirrhotic patients that develop a decompensation (ascites, variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome)(4 years)
  • Type of portosystemic shunts detected by angio-CT scan or MRI(4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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