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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Gastrointestinal bleeding [Срок оценки: 1 year]

Вторичные конечные точки (2)

• Gastrointestinal bleeding [Срок оценки: 6 months, 3 years, and 5 years]
• The occurrence of clinical events [Срок оценки: 6 months, 1 year, 3 years, and 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 10 центров

• Southern Medical University Nanfang Hospital — Гуанчжоу
• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• The First Affiliated Hospital of Nanchang University — Nanchang
• People's Liberation Army Northern Theater General Hospital — Шэньян
• Qilu Hospital of Shandong University — Цзинань
• Shandong Provincial Hospital — Цзинань
• Renji Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай
• Shanghai Changzheng Hospital — Шанхай
• … и ещё 2 центра

Идентификаторы

NCT: NCT06970509 · B2025-180R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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