Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Esophageal Varices, Portal Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Gastrointestinal bleeding [Time frame: 1 year]
Secondary outcome measures (2)
- Gastrointestinal bleeding [Time frame: 6 months, 3 years, and 5 years]
- The occurrence of clinical events [Time frame: 6 months, 1 year, 3 years, and 5 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 10 centers
- Southern Medical University Nanfang Hospital — Guangzhou
- The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
- The First Affiliated Hospital of Nanchang University — Nanchang
- People's Liberation Army Northern Theater General Hospital — Shenyang
- Qilu Hospital of Shandong University — Jinan
- Shandong Provincial Hospital — Jinan
- Renji Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
- Shanghai Changzheng Hospital — Shanghai
- … and 2 more centers
Identifiers
NCT: NCT06970509 · B2025-180R