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NCT06970509Recruiting

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

Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1450 (estimated)
First submitted
6 May 2025
Start date
1 Mar 2025
Primary completion date
31 Dec 2027
Lead sponsor
Shanghai Zhongshan Hospital
NCT number
NCT06970509

What you commit to

  • Study type: Observational
  • Planned participants: 1450
  • From 1 Mar 2025 to the primary completion date, 31 Dec 2027
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of severe life-threatening diseases of the circulatory, hematological, or respiratory systems;

Other

  • CT image slice thickness does not meet the requirements or there are artifacts;
  • Endoscopy shows no presence of esophageal and/or gastric varices;
  • Lack of important historical medical information or other relevant data.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Third Affiliated Hospital of Sun Yat-Sen University
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GuangzhouChinaRecruiting
Southern Medical University Nanfang Hospital
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GuangzhouChinaRecruiting
Shandong Provincial Hospital
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JinanChinaRecruiting
Qilu Hospital of Shandong University
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JinanChinaRecruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaRecruiting
Zhongshan Hospital
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ShanghaiChinaRecruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
Shanghai East Hospital
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ShanghaiChinaRecruiting
Shanghai Changzheng Hospital
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ShanghaiChinaRecruiting
People's Liberation Army Northern Theater General Hospital
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ShenyangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.