Improve the Strategies of Endoscopic and Interventional Treatment of Gastroesophageal Hemorrhage in Portal Hypertension
1 other identifier
observational
1,450
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
May 14, 2025
May 1, 2025
2.8 years
May 6, 2025
May 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastrointestinal bleeding
Gastrointestinal bleeding within 1 year
1 year
Secondary Outcomes (2)
Gastrointestinal bleeding
6 months, 3 years, and 5 years
The occurrence of clinical events
6 months, 1 year, 3 years, and 5 years
Study Arms (2)
Esophagogastric Variceal Characterization Model for Portal Hypertension Patients
We have previously preliminarily constructed an automatic segmentation model for intra- and extra-luminal esophageal vessels. This model was validated in the portal venous CT scans of 52 patients with cirrhosis and esophagogastric varices, yielding Dice, Jaccard, 95HD, and ASD scores of 0.903, 0.841, 5.428, and 0.959, respectively, indicating good segmentation performance of the model. To meet the requirements for feature extraction, modeling, and machine learning based on omics characteristics, at least 450 patients are needed. Based on the patient admission situation at our center, we plan to enroll 250 patients in the training set for modeling and 100 patients in the internal validation set, following a 2.5:1 allocation ratio. Other research centers are expected to enroll 100 patients as the external validation group.
Endoscopic and Pharmacological Therapy Prognostic Prediction Model
Taking anticoagulant use as an example, the incidence of portal vein thrombosis (PVT) in patients with portal hypertension is approximately 10-25%. The use of anticoagulant drugs can significantly improve the recanalization of portal vein thrombosis (hazard ratio = 1.3) and improve patient prognosis. With a 1:1 ratio of the two groups, a significance level of 0.05, and a power of 0.9, and following up for 180 days on events such as thrombus recanalization and rupture bleeding of esophageal and gastric varices, the sample size calculation formula for a two-sided test indicates that each group requires 448 cases. Considering a 10% dropout rate, 500 patients will be included in the personalized treatment group for varices and 500 in the traditional treatment group, totaling 1000 patients. Among them, our hospital plans to complete 700 cases, and the multicenter units will complete 300 cases.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
People's Liberation Army Northern Theater General Hospital
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Renji Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200000, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shiyao Chen, Ph.D.
Shanghai Zhongshan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 14, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2032
Last Updated
May 14, 2025
Record last verified: 2025-05