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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The data for the training group and internal validation group were derived from patients with portal hypertension and esophagogastric varices who visited Fudan University Zhongshan Hospital from January 1, 2019, to December 31, 2024. The enrolled patients were randomly divided into the training group and internal validation group at a ratio of 3:1. The external validation group was sourced from patients with portal hypertension and esophagogastric varices who visited participating institutions from January 1, 2019, to December 31, 2024.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,450 Participants
are grouped into 2 trial groups
Group A: Esophagogastric Variceal Characterization Model for Portal Hypertension Patients
Group B: Endoscopic and Pharmacological Therapy Prognostic Prediction Model

Trial outcomes

Primary outcomes

1

Gastrointestinal bleeding

Gastrointestinal bleeding within 1 year

Time frame
1 year

Secondary outcomes

1

Gastrointestinal bleeding

Gastrointestinal bleeding within 6 months, 3 years, and 5 years

Time frame
6 months, 3 years, and 5 years
2

The occurrence of clinical events

The occurrence of events such as ascites progression, overt jaundice, changes in portal vein thrombosis, hepatocellular carcinoma, liver transplantation, or survival and death within 6 months, 1 year, 3 years, and 5 years.

Time frame
6 months, 1 year, 3 years, and 5 years

Other outcomes

Sponsors and contacts

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