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

NCT06970509 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Zhongshan Hospital

Phase

Observational

Started

2025-03-01

Last updated

2025-05-14

Condition(s) studied

Esophageal VaricesPortal Hypertension

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Confirmed diagnosis of portal hypertension; 2. Underwent imaging and endoscopic examination or treatment within one week after admission; 3. Endoscopy revealed the presence of esophageal and/or gastric varices. Exclusion Criteria: 1. CT image slice thickness does not meet the requirements or there are artifacts; 2. Endoscopy shows no presence of esophageal and/or gastric varices; 3. Presence of severe life-threatening diseases of the circulatory, hematological, or respiratory systems; 4. Lack of important historical medical information or other relevant data.

Primary outcome measure(s)

Gastrointestinal bleeding — 1 year
Gastrointestinal bleeding within 1 year

Trial sites (10)

Facility	City	Region	Status
Southern Medical University Nanfang Hospital	Guangzhou	Guangdong	Recruiting
The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	Recruiting
The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	Recruiting
People's Liberation Army Northern Theater General Hospital	Shenyang	Liaoning	Recruiting
Qilu Hospital of Shandong University	Jinan	Shandong	Recruiting
Shandong Provincial Hospital	Jinan	Shandong	Recruiting
Renji Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality	Recruiting
Shanghai Changzheng Hospital	Shanghai	Shanghai Municipality	Recruiting
Shanghai East Hospital	Shanghai	Shanghai Municipality	Recruiting
Zhongshan Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06970509 on ClinicalTrials.gov ↗ ← All trials in China