NCT06970509

Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,450 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Esophageal Varices
• Portal Hypertension

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-12-01
• Completion: 2032-12-01
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

10 sites across 1 country: China