跳至主要内容
临床试验/NCT04820166
NCT04820166招募中不适用

The Effect of Monitoring Portal Venous Pressure on Clinical Outcomes in Patients With Portal Hypertension: a Prospective, Single-center, Observational Study

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Ascites

研究概览

简要总结

The complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. The level of portal venous pressure is closely related to the prognosis of patients. HVPG (hepatic venous pressure gradient) is the "gold standard" for predicting portal venous pressure and an important indicator for evaluating the efficacy of NSBBS. However, monitoring HVPG has many limitations,and the clinical application is also limited to a certain extent. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. At the same time, to explore the correlation between HVPG and PPG in cirrhosis patients at different stages and different etiologies, and to evaluate the role of spleen stiffness in predicting the severity of esophageal and gastric varices in patients with portal hypertension, and to find biomarkers to predict the risk of complications related to portal hypertension.

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

入选标准

  • With chronic liver disease
  • Age 18-80 years
  • Patients who require a portal pressure measurement at the discretion of the treating physician
  • Voluntarily signed informed consent

排除标准

  • With serious cardiopulmonary disease or other diseases affect survival
  • With severe renal dysfunction
  • Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis
  • Women who are planning to become pregnant or who are pregnant or breastfeeding
  • The researcher judged that it was not suitable to participate in this study

结局指标

主要结局

Ascites

时间窗: three years

Peritoneal effusion was seen under ultrasound

Hepatic encephalopathy

时间窗: three years

Patients with altered consciousness or unresponsiveness, accompanied by elevated blood ammonia

Gastroesophageal varices bleeding

时间窗: three years

Patients with gastroesophageal varices has hematemesis or melena, and active bleeding or red sign can be seen under endoscopy

次要结局

  • Death or final follow-up time (3 years)(three years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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