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NCT Number: NCT06970509

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Gastrointestinal bleeding

    Time frame: 1 year

    Gastrointestinal bleeding within 1 year

Secondary outcomes

  1. Gastrointestinal bleeding

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

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

  2. The occurrence of clinical events

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yiting Wang, Ph.D.

CONTACT

[email protected]

+86-15221919860

xiaoquan huang, M.D.

CONTACT

[email protected]

+86-18801733835

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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