跳至主要内容
临床试验/NCT03989973
NCT03989973Unknown不适用

West China Hospital, Sichuan University

West China Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Liver Stiffness

研究概览

简要总结

The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.

详细描述

Variceal bleeding is a fatal complication in patients with liver cirrhosis. A screening esophagogastroduodenoscopy (EGD) is recommended in all patients with cirrhosis to identify those patients at risk of variceal bleeding. However, this technique is invasive, uncomfortable and costly. Moreover, with the development of noninvasive technology for early diagnosis of liver cirrhosis, half of these patients will not develop varices within 10 years and therefore will undergo unnecessary EGD screening. Thus, the need for noninvasive screening methods for varices in patients with cirrhosis is urgent.

2D-SWE is a promising new type of shear wave-based ultrasound technique for measuring LS. The shear waves are generated directly within the tissue by acoustic radiation force impulse, allowing the measurement of stiffness in patients with ascites. In addition, the LS values can be obtained on the basis of anatomic information to avoid major vessels and control major measurement bias. 2D-SWE has been reported to have high reliability and reproducibility in assessing liver stiffness. Several studies compared TE with 2D-SWE in predicting fibrosis stages and portal hypertension, which suggested that 2D-SWE has a higher technical success rate and a better diagnostic value for portal hypertension than TE.The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.

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
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cirrhosis were diagnosed by liver biopsy, CT and ultrasound before enrolled
  • Age was 16-80

排除标准

  • With bleeding history
  • With EVL history, BRTO or TIPS history
  • With NSBB history
  • With ascites
  • With splenectomy or splenic embolism, history
  • With liver cancer

结局指标

主要结局

Liver Stiffness

时间窗: 1 day (At 2D-SWE scanning time)

Liver stiffness assessed by 2D-SWE

Varices stage

时间窗: 1 day (At gastroscopy performed time)

Gastroscopy was used to assess varices stage

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

luo xuefeng

Associate Professor

West China Hospital

研究点 (1)

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