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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06970509
Enrollment
1450
Registered
2025-05-14
Start date
2025-03-01
Completion date
2032-12-31
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Varices, Portal Hypertension

Keywords

Endoscopic Treatment

Brief 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.

Interventions

None listed

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gastrointestinal bleeding1 yearGastrointestinal bleeding within 1 year

Secondary

MeasureTime frameDescription
Gastrointestinal bleeding6 months, 3 years, and 5 yearsGastrointestinal bleeding within 6 months, 3 years, and 5 years
The occurrence of clinical events6 months, 1 year, 3 years, and 5 yearsThe 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.

Countries

China

Contacts

Primary ContactYiting Wang, Ph.D.
wang.yiting@zs-hospital.sh.cn+86-15221919860
Backup Contactxiaoquan huang, M.D.
huang.xiaoquan@zs-hospital.sh.cn+86-18801733835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026