跳至主要内容
临床试验/NCT06970509
NCT06970509招募中不适用

Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension: Novel Strategies for Diagnosis, Treatment and Prognostic Assessment System of Cirrhotic Portal Hypertension

Shanghai Zhongshan Hospital10 个研究点 分布在 1 个国家目标入组 1,450 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,450
试验地点
10
主要终点
Gastrointestinal bleeding

研究概览

简要总结

Endoscopic esophageal variceal ligation combined with gastric variceal embolization using tissue glue is currently the first-choice method for preventing rebleeding in patients with cirrhosis and portal hypertension. However, the rebleeding rate remains relatively high. Factors such as extra-luminal vascular bundles in the esophagus and stomach walls, and portosystemic shunts significantly affect the therapeutic outcomes. Therefore, there is an urgent need to develop an individualized treatment model for esophagogastric varices based on the anatomical and hemodynamic characteristics of the varices, to stratify patient risks and provide tailored treatment options.

Before the treatment of esophagogastric varices, the vascular characteristics of esophagogastric varices are assessed based on imaging data such as portal venous CT and ultrasound, as well as clinical information. Risk factors influencing bleeding from esophagogastric varices are explored, and an endoscopic and interventional variceal stratification and treatment model is constructed to provide patients with personalized options for endoscopic or interventional therapy.

During the treatment of esophagogastric varices, precise endovascular embolization of the source branch vessels of esophagogastric varices is performed based on hemodynamic models. The safety and efficacy of this treatment strategy are verified through randomized controlled clinical trials.

After the treatment of esophagogastric varices, the feasibility of reducing the risk of rebleeding in patients with poor endoscopic outcomes is examined by using drugs that lower portal venous pressure, such as carvedilol or novel oral anticoagulants. Factors influencing recompensation and reversal of portal hypertension are also clarified.

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
否

入选标准

  • •Confirmed diagnosis of portal hypertension;
  • •Underwent imaging and endoscopic examination or treatment within one week after admission;
  • •Endoscopy revealed the presence of esophageal and/or gastric varices.

排除标准

  • •CT image slice thickness does not meet the requirements or there are artifacts;
  • •Endoscopy shows no presence of esophageal and/or gastric varices;
  • •Presence of severe life-threatening diseases of the circulatory, hematological, or respiratory systems;
  • •Lack of important historical medical information or other relevant data.

结局指标

主要结局

Gastrointestinal bleeding

时间窗: 1 year

Gastrointestinal bleeding within 1 year

次要结局

  • Gastrointestinal bleeding(6 months, 3 years, and 5 years)
  • The occurrence of clinical events(6 months, 1 year, 3 years, and 5 years)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (10)

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